Systems for defining and modifying range of motion of probe used in patient treatment

ABSTRACT

A system for treating a target tissue of a patient comprises a first robotic arm coupled to a treatment probe for treating the target tissue of the patient, and a second robotic arm coupled to an imaging probe for imaging the target tissue of the patient. The system further comprises one or more computing devices operably coupled with the first robotic arm and the second robotic arm, the one or more computing devices configured to execute instructions for controlling movement of one or more of the first robotic arm or the second robotic arm. The treatment probe and/or imaging probe may be constrained to be moved only within an allowable range of motion.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.17/304,572, filed Jun. 23, 2021, which is a continuation of U.S. patentSer. No. 16/939,880, filed Jul. 27, 2020, now U.S. Pat. No. 11,096,753,issued Aug. 24, 2021, which application claims the benefit under 35U.S.C. § 119(e) of U.S. Provisional Patent Application No. 63/044,843,filed Jun. 26, 2020, the disclosures of which are incorporated, in theirentirety, by this reference.

The subject matter of this patent application is related toInternational Application No. PCT/US2015/048695, filed Sep. 4, 2015,published as WO 2016/037137 on Mar. 10, 2016, and InternationalApplication No. PCT/US2020/021756, filed Mar. 9, 2020, published as WO2020/181290, on Sep. 10, 2020, the entire contents of which applicationsare incorporated herein by reference.

BACKGROUND

The field of the present disclosure is related to the treatment oftissue with energy, and more specifically to the treatment of an organsuch as the prostate with fluid stream energy.

Prior methods and apparatus of treating subjects such as patients canresult in less than ideal tissue removal in at least some instances. Forexample, prior methods of surgery such as prostate surgery can result inlonger healing time and a less than desirable outcome than would beideal in at least some instances.

Prior methods and apparatus of imaging tissue can be less than ideal forimaging a treated tissue. For example, prior ultrasound methods andapparatus may not be well suited to view the treatment site duringtreatment, and alignment of diagnostic images with treatment images canbe less than ideal. Also, at least some of the prior treatment methodsand apparatus of treating tissue may not be well suited for combinationwith imaging systems of the prior art. In at least some instances, itwould be helpful to provide improved imaging of tissue during surgery,for example to provide real time imaging of tissue that would allow auser to adjust the treatment based on real time images of the tissue. Atleast some of the prior methods and apparatus to image tissue duringsurgery can be somewhat cumbersome to use and can result in delays inthe patient treatment.

Prior methods and apparatus to treat an organ such as the prostate mayprovide a user interface that is somewhat cumbersome for the user andcan provide less than ideal planning of the surgery, such as by notproviding sufficient images of probes and treatment areas, not providing“fine” enough controls of probes or not providing indications ofconstraints on probe motion that may impact the planning process, etc.Also, at least some of the prior methods and apparatus used to treattissue such as the prostate tissue can be somewhat less accurate thanwould be ideal, such as by showing inaccuracies in the placement of anorgan, misidentifying tissue, creating uncertainty as to whether theapplication of a treatment is to the correct area or region, etc. In atleast some instances, the prior methods and apparatus may provide a lessthan ideal user experience (for example, excessive manual operationswhich could be accomplished automatically). Also, at least some of theprior interfaces may provide less than ideal coupling of the treatmentapparatus with tissue structures (for example, by lacking images and/orcontrols that would enable more accurate and informed control of atreatment procedure by a physician).

For at least the reasons mentioned, prior methods and apparatus oftreating tissue with robotic instrumentation can be less than idealduring a treatment. The robotic arms and surgical probes of a roboticsurgery system may be aligned with one another and with the patientprior to the treatment. In some instances, the robotic arms and surgicalprobes are first manually moved and positioned before they are coupledto each other and locked in position for further controller-basedadjustments. For example, a surgical probe or other tool coupled to arobotic arm may be manually guided through the anatomy to reach a targetsite, such as through the anus and rectum in the case of transrectalultrasound (“TRUS”), or through the tortuous path of the urethra,prostate, and bladder neck which involves sharp turns through sensitiveanatomy. In at least some instances, the maintenance of the desiredalignment and the stability of the robotic arms after the manualadjustment and during treatment can be less than ideal. For example, theprior robotic arms and end surgical probes could be held too rigidlywhich could potentially lead to tissue injury related to patientmovement, or may be held with less than ideal support strength, whichcould lead to less than ideal alignment with the target site if therobotic arms and surgical probes were to be disturbed, e.g. upon beingbumped or being released from the grasp of a user subsequent tocoupling.

A further disadvantage of prior methods and apparatus of treating tissuewith robotic instrumentation is that the probes and devices used fortreatment, and in some cases for monitoring treatment, have a range ofpossible motions that in some cases, could cause the probes and devicesto collide with each other during treatment in some instances. Thiscould potentially lead to a less than ideal outcome and an interruptionin the treatment. The prior approaches can be somewhat limited in theability to customize the allowable range of motion for an individualpatient, even though the absolute and relative positions of the roboticarms may be known.

Work in relation to the present disclosure suggests that priorapproaches to aligning probes with robotic arms can be less than idealin at least some instances.

While these aforementioned methods and apparatuses can be effective andmay represent a significant advance over prior luminal tissue treatmentapproaches, it would be desirable to provide improvements to assist inmore accurate tissue removal in both fully automated and physicianassisted operating modes. At least some of these limitations of theprior approaches will be overcome in accordance with embodiments of thepresent disclosure.

SUMMARY

Embodiments of the present disclosure provide improved movement ofrobotic arms and are well suited for use with surgical procedures. Insome embodiments, a robotic arm is configured to enter into a teachingor training mode that can allow range of motion limits or constraints tobe established for a probe inserted into a patient. The probe coupled tothe robotic arm can be moved within the patient by an operator toestablish positions that are appropriate for the patient and thetreatment. Also, the pivot location of the probe can be established.With prostate surgery, the pivot location of a surgical probe insertedinto the patient can be established so as to correspond to the pubicbone. Similarly, the TRUS or imaging probe can be inserted into thepatient to establish ranges of motion and a pivot location at a locationcorresponding to the rectum. Because patient anatomy can vary,establishing ranges of motion for probes and their associated pivots canbe helpful. In some embodiments, a pivot location corresponding to therectum can be located caudal or cephalad to the pivot locationcorresponding to the treatment probe. Once the ranges of motion andpivot locations have been established, the operator can then preciselyposition the probes under robotic control. The imaging probe can also beused to determine the position and orientation of the treatment probe,with that information being used to limit movement of the treatmentprobe toward the imaging probe. Although reference will be made to useof robotic arms and probes for purposes of imaging and treatment, thesystems and methods described herein may also be used for diagnosticpurposes, as part of treatment planning, as part of post-treatmentexamination, etc.

Embodiments of the present disclosure provide improved methods andapparatus for performing tissue treatment such as, but not limited totissue resection. In some embodiments, an image-guided treatment systemcomprises a treatment probe and an imaging probe. The imaging probe maybe configured to provide an image of the target site while the treatmentprobe performs resection or other treatment of the target tissue. Insome embodiments, the treatment probe and the imaging probe are eachcoupled to robotic arms under control of one or more computing devices.The treatment probe may be coupled to a first robotic arm configured toprovide computer-controlled movement of the treatment probe duringtissue resection with the treatment probe. The imaging probe may becoupled to a second robotic arm configured to providecomputer-controlled movement of the imaging probe during scanning of thetarget site with the imaging probe, before and/or during the tissueresection procedure with the treatment probe. One or more computingdevices or processors may be configured to execute instructions foroperating the robotic arms in a passive mode in which the robotic armsare configured to be manually adjusted to position the treatment andimaging probes to a manually-set position, such as for imaging andtreatment of the same or different tissue sites. The one or morecomputing devices may be configured to execute instructions formaintaining the manually set position(s) of the probes after the roboticarms are released from the manual adjustment or passive mode. Therobotic arms may be configured to maintain the manually set positionwith respect to one or more of a translational axis or a rotationalaxis. In some embodiments, the rotational angle is maintained to within5° and the translational position to within 5 mm, or less. In someembodiments, the rotational angle and translational position aremaintained for each of three axes, which can improve the accuracy ofimaging and treatment with a probe.

The one or more computing devices operably coupled to the first andsecond robotic arms may be configured to automatically control themovement of the treatment probe and/or the imaging probe, for examplebased on a pre-planned or programmed scanning profile, or according tovarious pre-programmed parameters. The treatment pre-planning may beperformed manually and/or with the assistance of one or more of computervision, image recognition, or machine learning. The automaticallycontrolled movement of the treatment probe in accordance with atreatment profile can perform treatment of the target site, for example.The automatically controlled movement of the image probe in accordancewith an imaging profile can generate a 3-dimensional rendering of thetarget site, for example. The automatic, computer-controlled scanning ormonitoring of the target site with the imaging probe using the roboticarm can also be used to generate useful information regarding the targetsite for purposes of preventing harm to the patient or for additionaltreatment. For example, the imaging probe may be configured to perform acolor/Doppler scan of the target site after a resection procedure, inorder to locate bleeding sites within the target site that requirehemostasis. As another example, the imaging probe may be configured toperform a color/Doppler scan of the target site before a resection orother procedure, in order to locate blood vessels and enabling thesurgical planning to avoid potential bleeding sites, thereby avoiding apost procedure requirement for hemostasis treatment. The 3-dimensionalscan of the target site using the imaging probe may also be used toidentify tissue anomalies at the target site, such as tumors. A scan orimaging may also be performed pre or post-operation or treatment andcompared to a later scan or image to identify bleeding or other issues.

Alternatively, or additionally, the one or more computing devices may beconfigured to control movement of the treatment probe and/or the imagingprobe in response to user inputs, for example through a graphical userinterface of the treatment apparatus. In some embodiments, the one ormore computing devices may be configured to limit the movement of thetreatment probe and/or imaging probe within an allowable range ofmotion, which may be programmed into the first and/or second robotic armprior to initiating use of the first or second arm under computercontrol.

In some embodiments, the disclosure is directed to a system for treatingor imaging tissue of a patient. In these embodiments, the system mayinclude a probe sized for insertion into the patient, a robotic armconfigured to couple to the probe, one or more computing devicesoperatively coupled to the robotic arm and configured with instructionsfor establishing an allowable range of motion for the probe, with theallowable range of motion stored on a memory of the one or morecomputing devices. In these embodiments, establishing the allowablerange of motion includes defining a possible range of motion for adistal end of the probe and modifying the possible range of motion ofthe distal end of the probe to define an allowable range of motion forthe distal end of the probe for an individual patient. In someembodiments, this approach allows the allowable range of motion to beestablished for an individual patient and to be customized for eachpatient. The instructions also include instructions for treating orimaging the target tissue of the patient with the probe and moving therobotic arm to affect movement of the probe within the allowable rangeof motion for the probe.

In some embodiments, the one or more computing devices may be configuredto limit or constrain the movement of the treatment probe and/or imagingprobe within an allowable range of motion based on one or more oftraining or motion adjusting steps.

In some embodiments, the training or motion adjusting steps may includeproviding a computer system used to control the robotic arms andattached probes with data regarding the possible range of motion of eachprobe. This data may be provided in the form of a mathematicalrepresentation of the respective possible range of motion for each probeor an image showing the possible range of motion along with indicationsof the amounts of translational and/or angular motion that are possible.The possible range of motion for one or more probes may then be limitedor constrained to an allowable range of motion by a training or teachingmode or session.

In some embodiments, the training or motion adjusting steps may includeproviding a computer system used to control the robotic arms andattached probes with data obtained from a training or teaching mode orsession. In such a mode or session, a physician may manipulate the probeor probes while inside a patient's body to “teach” the computer systemwhat constraints or boundaries to place on the possible range of motionof each probe. This may be done to prevent harm to a patient, such asdamage to tissue or an organ. A training or teaching mode may also (orinstead) be conducted when the probes are outside of a patient's body.During a training mode, the computer system learns the limits to applyto the possible range of motions to prevent harm to the patient, and inresponse prevents the robotic arms from being able to position theprobes in a harmful position or orientation. A training mode conductedoutside the body is especially effective in training probe location andenabling anti-collision capability in the control system.

In some embodiments, the training or motion adjusting steps may includeproviding a computer system used to control the robotic arms andattached probes with images obtained from a monitoring or imaging probe(such as the TRUS probe described herein). In these embodiments, themonitoring or imaging probe can be used to provide images of thetreatment probe and surrounding tissue and organs, and the computersystem can be configured to control the position, orientation, ormovement of the probes to prevent harm to the patient and/or a collisionbetween the probes based on the images. In some embodiments, an imagerecognition method may be used to assist the computing system toidentify a patient's tissue or organs. In some embodiments, a CT, MRI orother scan of the patient may be used to assist the image recognitionsystem to identify the patient's tissue or organs and/or to determineappropriate limits or constraints on a possible range of motion of aprobe.

In some embodiments, the disclosure is directed to a method of treatingtarget tissue at a target site of a patient, where the method includesmanually inserting a probe into the patient, coupling the probe to arobotic arm, establishing an allowable range of motion for the probewith the allowable range of motion stored on a memory of one or morecomputing devices operably coupled with the robotic arm. In theseembodiments, establishing the allowable range of motion furthercomprises defining a possible range of motion for a distal end of theprobe and modifying the possible range of motion of the distal end ofthe probe to define an allowable range of motion for the distal end ofthe probe for an individual patient. The method further includestreating or imaging the target tissue of the patient with the probe andmoving the robotic arm under control of the one or more computingdevices operably coupled with the probe, to affect movement of the probewithin the allowable range of motion for the probe.

In some embodiments, the disclosure is directed to a system for treatingtarget tissue at a target site of a patient, where the system includes afirst robotic arm coupled to a treatment probe for treating the targettissue of the patient, a second robotic arm coupled to an imaging probefor imaging the target tissue of the patient and one or more computingdevices operably coupled with the first robotic arm and the secondrobotic arm, the one or more computing devices configured to executeinstructions for controlling movement of one or more of the firstrobotic arm or the second robotic arm, wherein the instructionsconstrain the movement of one or both probes to be within an allowablerange of motion for the probe or probes.

The first robotic arm and/or the second robotic arm may be configured toadjust the position and/or orientation of the first arm and/or thesecond arm to maintain proper position or alignment of the treatmentprobe and the imaging probe, and/or to prevent collision or interferencebetween the treatment probe and the imaging probe outside of thepatient's body.

The first robotic arm and/or the second robotic arm may comprise one ormore feedback sensing mechanisms. For example, the first robotic armand/or the second robotic arm may be operably coupled with a forcesensor configured to detect a compression of the tissue anterior to thetreatment probe and/or imaging probe. The one or more computing devicesmay comprise instructions to control movement of the robotic arms inresponse to forces detected by the sensor, for example to preventover-compression of the anterior tissue and resultant damage to thetissue and/or the probe. Another exemplary feedback sensing mechanismmay comprise position and/or motion sensors operably coupled with thefirst and/or second robotic arm. The one or more computing devices maycomprise instructions to control movement of the robotic arms inresponse to the position and/or motion detected by the sensors, forexample to adjust the position of the treatment and/or imaging probe inresponse to patient movement during a treatment and/or scanningprocedure.

These and other embodiments are described in further detail in thefollowing description related to the appended drawing figures.

INCORPORATION BY REFERENCE

All publications, patents, and patent applications mentioned in thisspecification are herein incorporated by reference to the same extent asif each individual publication, patent, or patent application wasspecifically and individually indicated to be incorporated by reference.

BRIEF DESCRIPTION OF THE DRAWINGS

The novel features of the invention are set forth with particularity inthe appended claims. A better understanding of the features andadvantages of the present disclosure will be obtained by reference tothe following detailed description that sets forth illustrativeembodiments, in which the principles of the present disclosure areutilized, and the accompanying drawings of which:

FIG. 1 shows a front view of a system for performing tissue resection ina patient, in accordance with some embodiments;

FIG. 2 schematically illustrates a system for performing tissueresection in a patient, in accordance with some embodiments;

FIGS. 3A and 3B show perspective views of a common base or mount forsupporting one or more robotic arms, in accordance with someembodiments;

FIGS. 4A and 4B illustrate a perspective and side view, respectively, ofa system for performing tissue resection in a patient that comprises amobile base, in accordance with some embodiments;

FIGS. 5A and 5B show top views of a coupling between a treatment probeand a first robotic arm, in accordance with some embodiments, with FIG.5A showing the treatment probe and the first robotic arm uncoupled andFIG. 5B showing the treatment probe and the first robotic arm coupled;

FIG. 6 shows a flow chart for a method of operating a robotic armcoupled to a treatment probe, in accordance with some embodiments;

FIG. 7 shows a method for operating a robotic arm coupled to an imagingprobe in accordance with some embodiments;

FIG. 8A illustrates a configuration of a treatment probe and an imagingprobe during treatment of a patient, in accordance with someembodiments;

FIG. 8B is a schematic illustration of a probe and a robotic arm withforce detection sensors, in accordance with some embodiments;

FIGS. 9A, 9B, and 9C schematically illustrate an alignment of atreatment probe axis with a sagittal plane of an imaging probe, inaccordance with some embodiments;

FIG. 10 shows an intra-operative image of a surgical field including theidentification of bleeding sites, in accordance with some embodiments;

FIG. 11 illustrates a system for locating and calibrating one or moreprobes, in accordance with some embodiments;

FIG. 12 illustrates an arm coupled to a sheath, a robotic arm coupled toa treatment probe, and an arm coupled to an ultrasound probe, inaccordance with some embodiments;

FIG. 13 illustrates a system comprising a robotic arm coupled to atreatment probe and an arm coupled to a sheath as in FIG. 12 ;

FIG. 14A illustrates a coupling to couple a robotic arm to a treatmentprobe;

FIG. 14B illustrates movements of the treatment probe, the endoscope,the irrigation lumen and the aspiration lumen provided by the couplingas in FIG. 14A;

FIG. 15 illustrates a method of treatment, in accordance with someembodiments;

FIG. 16 illustrates a side view of a handpiece or treatment probe andshows an example range of motion (ROM) about a ROM origin point of theprobe for the distal end of the probe from that perspective, inaccordance with some embodiments;

FIG. 17 illustrates the treatment probe of FIG. 16 and shows an exampleof a possible range of motion (ROM) for the distal end of the probe, inaccordance with some embodiments. The figure also illustrates a possiblerange of motion for the probe about a pivot point representing thelocation on the probe wand beyond which the probe is inserted into apatient's body;

FIG. 18 illustrates a top view of the handpiece or treatment probe ofFIG. 16 and shows an example range of motion about a range of motionorigin point of the probe for the distal end of the probe from thatperspective, in accordance with some embodiments;

FIG. 19 illustrates the treatment probe of FIG. 18 and shows an exampleof a possible range of motion (ROM) for the distal end of the probe, inaccordance with some embodiments. The figure also illustrates a possiblerange of motion for the probe about a pivot point representing thelocation on the probe wand beyond which the probe is inserted into apatient's body;

FIG. 20 illustrates a side view of an imaging probe and an example of arange of motion for the distal end of the probe about a pivot point fromthat perspective, in accordance with some embodiments;

FIG. 21 illustrates a top view of the imaging probe of FIG. 20 and anexample of a range of motion for the distal end of the probe about apivot point from that perspective, in accordance with some embodiments;

FIG. 22 illustrates a side view of a treatment probe and an imagingprobe and shows the respective ranges of motion of the distal end ofeach probe overlaid with each other from that perspective, in accordancewith some embodiments;

FIG. 23 illustrates a top view of the treatment probe and imaging probeof FIG. 22 and shows the respective ranges of motion of the distal endof each probe overlaid with each other from that perspective, inaccordance with some embodiments;

FIG. 24 illustrates an isometric view of a treatment probe and animaging probe and shows the respective ranges of motion of the distalends of the probes overlaid with each other from that perspective, inaccordance with some embodiments;

FIG. 25A illustrates a side view of the treatment probe and imagingprobe of FIG. 24 and shows the respective ranges of motion of the distalends of the probes overlaid with each other from that perspective, inaccordance with some embodiments;

FIG. 25B illustrates a side view of the treatment probe and imagingprobe of FIG. 24 and shows the respective ranges of motion of the distalends of the probes overlaid with each other from that perspective, inaccordance with some embodiments. Note that in this figure, the imagingprobe is advanced horizontally or longitudinally with respect to thetreatment probe in comparison to FIG. 25A;

FIG. 26 illustrates a top view of the treatment probe and imaging probeof FIG. 25A and shows the respective ranges of motion overlaid with eachother when the probes are separate but colinear or parallel to eachother, in accordance with some embodiments; and

FIG. 27 is a flowchart or flow diagram illustrating a method, process,operation or function for setting a range of motion (ROM) for a probeused as part of a procedure to treat a patient, in accordance with someembodiments.

DETAILED DESCRIPTION

Embodiments of the present disclosure provide improved methods andapparatus for performing tissue treatment such as tissue resection, forexample prostate tissue resection.

The methods and apparatus disclosed herein are well suited for manytypes of surgical procedures and can be incorporated into many priorsystems and methods. While some embodiments of the present disclosureare directed to transurethral treatment of the prostate, some aspects ofthe present disclosure may also be used to treat and modify othertissues and associated organs. These other tissues and associated organsmay include but are not limited to the brain, heart, lungs, intestines,eyes, skin, kidney, liver, pancreas, stomach, uterus, ovaries,testicles, bladder, ear, nose, mouth, soft tissues such as bone marrow,adipose tissue, muscle, glandular and mucosal tissue, spinal and nervetissue, cartilage, hard biological tissues such as teeth, bone, as wellas body lumens and passages such as the sinuses, ureter, colon,esophagus, lung passages, blood vessels, and throat. The devicesdisclosed herein may be inserted through an existing body lumen orinserted through an opening created in body tissue.

The presently disclosed methods and apparatus are well suited fortreating many types of tissue with an energy source. The tissue maycomprise soft tissue, such as glandular tissue or capsular tissue, orhard tissue such as bone or blockages, such as kidney stones, forexample. The energy source may comprise one or more of a laser beam, awater jet, an electrode, ultrasound, high intensity focused ultrasound,mechanical vibrations, radiofrequency (RF) energy an ultrasoundtransducer, microwave energy, cavitating energy such as a cavitatingwater jet or ultrasonic cavitations, radiation such as ionizingradiation from a radioisotope, or ion energy from ionization electrodesor plasma energy from plasma electrodes. The presently disclosed methodsand apparatus are well suited for performing lithotripsy to break upkidney stones, for example. The presently disclosed methods andapparatus are well suited for treatment with radiation, such as a radioisotope on the treatment probe. The radiation treatment can be providedon the probe and removed with the probe, or implanted from the treatmentprobe, for the treatment of cancer for example.

In some embodiments, an image-guided treatment system comprises atreatment probe and an imaging probe. The imaging probe may beconfigured to provide an image of the target site while the treatmentprobe performs resection or other treatment of the target tissue. Thetreatment probe and the imaging probe may each be coupled to roboticarms under control of one or more computing devices, in order to enablemore precisely controlled movement of one or both of the arms and toimprove the safety and efficiency of treatment using the treatmentsystem. The treatment probe and the imaging probe may instead or also beunder the control of signals received from a joystick, GUI or other formof manual controller.

The robotic arms can be configured in many ways. Work in relation to thepresent disclosure suggests that a TRUS probe can exert force on arobotic arm. In some embodiments this force is related to force from thepatient against the probe. In some embodiments this force is related toforce caused by the practitioner surgeon moving the probe against tissueand moving the tissue for the purpose of improving imaging or tissueposition relative to the intended treatment. The length of the probe canresult in a corresponding torque on the robotic arm. Collisions betweenprobes or between a probe and a patient's organs or tissue can causeforces on the robotic arms that can impact their positioning precisionand control.

The present inventors have conducted experiments to determine the amountof force from the TRUS probe that can be applied to the robotic arm.This force can be measured at a motor mount exterior to the patient, forexample. The force can range from 0 to about 49 Newtons, depending onthe surgical placement of the probe and patient. In some embodiments,the distance from the arm to the point of contact with prostatecorresponds to an amount of torque on the arm.

Instrument positioning can have three categories of motion control andcapability in accordance with some embodiments disclosed herein. Thethree categories of motion generally comprise a 1) coarse motioncapability for movement, storage and preparation for surgery, 2) anintermediate movement capability for aligning the probe with the patientand inserting the probe into the patient, and 3) a fine movementcapability corresponding to positional tolerances for accurate surgery.

Coarse motion capability allows for storage below and adjacent to thetable and during patient positioning, for example.

Intermediate motion allows for instrument positioning with respect tothe patient on the surgical support structure, e.g. an operating room(“OR”) table, for example when the system is being prepared andpositioned for patient entry. A typical range of position for the TRUSprobe or any suitable surgically invasive probe is to have free motionfor insertion into the patient, which can be describe with a X,Y,Zcoordinate system. With an appropriate coordinate reference system, theentry to a lumen of the patient may correspond to values of 0, 0, 0 inan X,Y,Z coordinate system. The coordinate reference may also compriseangular coordinate references of X′,Y′,Z′. The entry to the lumen maycomprise an anus of the patient. With an anal entrance at 0,0,0 and theprobe colinear with the patient axis, the intermedia motion may comprisean X motion tolerance of +/−2 to 15 cm, Y motion tolerance of +/−2 to 15cm, and Z motion tolerance of +/−2 to 30 cm. In some embodiments, the Xand Y motion corresponds to translation of the probe along the X and Ycoordinate references. The Z axis position corresponds to movement alongan axis of the lumen and may correspond to advancement and retraction ofthe probe along the body lumen, e.g. translational movement into and outof the patient. With an angular adjustment of X′,Y′, Z′, the angularposition capability may comprise X′+/−zero to 30 degrees, Y′+/−zero to30 degrees, Z′+/−zero to 30 degrees, with respect to the natural axis ofthe patient. Work in relation to the present disclosure suggests that aprobe with these angular capabilities can be manipulated by a user forinsertion into the patient.

In some embodiments, the fine movement capability and tolerancescorrespond to a configuration of the robotic probe and arms with theprobe positioned in the patient, for example during tissue resection andimaging. When the system is in use with instruments positioned fordiagnosis and treatment, the sensors and controls and described hereincan be configured to prevent tissue damage, and also to position atreatment probe and an imaging probe to obtain reliable images, e.g.optimal images, and the treatment and imaging probes can be preciselypositioned and firmly held in position against tissue pressures. TheX,Y,Z reference frame can be centered on the lumen entrance at 0,0,0 and(the probe colinear with the patient axis). In some embodiments, Xmotion tolerance is +/−0 to 5 cm; the Y motion tolerance is +/−0 to 5cm; and Z motion tolerance is +/−0 to 15 cm. The X and Y motiongenerally corresponds to translation of the probe, and the Z axiscorresponds to advancement and retraction of the probe in and out of thepatient. The corresponding angular adjustment ranges for X′,Y′,Z′ areX′+/−zero to 10 degrees, Y′+/−zero to 10 degrees, and Z′+/−zero to 15degrees, with respect to a natural axis of the patient, for example withreference to a midline of the patient with the Z axis extending alongthe midline of the patient. While the above values represent exampleranges of motion, the robotics arms and surgical probes may providetighter tolerances for fixed position configurations of the probe. Forexample, when the probe is intended to be held in a fixed position, therotational tolerances can maintain one or more of X′,Y′,Z′ within awithin +/−5° tolerance or less, e.g. +/−3°. With respect totranslational movement, the manually set position can be maintained to apositional tolerance of 5 mm or less, 3 mm or less, or 2 mm or less forone or more of the X, Y, Z axes, for example. In some embodiments, thesetolerances are maintained for each of X, Y, Z and X′, Y′, Z′. In someembodiments, the probe is manually set, and the translational androtational tolerances are maintained to within the above values, whichcan improve the accuracy of the tissue treatment and associated imaging.These tolerances may correspond a maximal structural relaxing or loadingof the arm with the probe mounted thereon, for example.

The probe can be manipulated and inserted into the patient in many ways.For example, the probe can be manipulated manually, and the robotic armmoved into alignment with the probe and coupled to the probe, with theprobe maintaining the above tolerances when released by the user and thearm subsequently supporting the full load of the patient and probes. Thearm can be brought into alignment with the probe manually, or with atleast some automation in which sensors and guidance circuitry are usedto bring the arm into alignment with the probe held by the user. The armmay comprise a coupling structure to engage the probe with 6 degrees offreedom, such that a coupling structure on the arm can be brought intoprecise alignment with the coupling structure on the probe. The couplingstructures can be subsequently engaged and coupled to each other inresponse to detection of the alignment. In some embodiments, sensors areprovided on one or more of the arm or the probe to detect alignmentbetween the arm and probe, and the coupling structures engaged inresponse to the detected alignment. The robotic arm may comprise alinkage coupled to a processor or computing device, in which theprocessor or device controls movement of the arm and brings the arm intoalignment with the probe held by the user.

In some embodiments, the urethral probe has similar dimensional, motionand tolerance capabilities to the TRUS probe.

In some embodiments, the probe comprises a mass within a range fromabout 250 grams to 1500 grams, and the arm maintains the tolerancesdescribed herein with the probe comprising the mass within this range.

The robotics arms as described herein can improve alignment between thetreatment probe and the imaging probe, which may comprise a sagittalplane of an imaging TRUS probe. For example, the treatment probe bealigned substantially coplanar along the sagittal plane of the imagingprobe. This coplanarity can provide clear imaging and alignment ofcoordinates of the treatment probe and imaging probe. In someembodiments, the tolerance of this coplanarity is related to thecombination of the width of the treatment probe and the width of theimaging plane capability, e.g. width of the image captured withultrasound beam forming. The relative position of the TRUS to thetreatment probe can be substantially parallel and aligned within anangular tolerance. The alignment can be within a range from +/−zero(parallel) to about 30 degrees. In some embodiments, the elongate axisof the treatment probe and TRUS probe are aligned in a substantiallyco-planar configuration, with the separation distance between the probesvarying along the length of the imaging and treatment probes. Forexample, the distal tip of the treatment probe can be farther away fromthe TRUS probe and the proximal end closer to the TRUS probe, in whichthe two probes are inclined relative to each other, althoughsubstantially coplanar. The inclination between the two probes can berelated to the tissue or organ constraints of natural orifices of eachunique human or patient anatomy. The distances between the entrances tothe naturally available orifices can vary, for example within a rangefrom about 5 cm to about 25 cm separation.

In some embodiments, the imaging probe and the treatment probe arealigned so that the treatment probe is within the field of view of theimaging probe. In some embodiments, the alignment is configured tomaintain the treatment probe within a field of view of the imagingprobe. In some embodiments, the treatment probe is configured to move toa position and the imaging probe is configured to maintain the treatmentprobe within the field of view. In some embodiments, this provides formonitoring of the position and orientation of the treatment probe duringtreatment and can reduce the possibility of harm to a patient.

In some embodiments, the monitoring of the position and orientation ofthe treatment probe by the imaging probe can generate a signal to acomputing device to stop movement of one or both probes or to alter theposition, location or orientation of one or both probes to prevent acollision between the probes while inside a patient's body and/or toprevent harm to a patient's tissue or organs. In some embodiments,monitoring of the position and orientation of the treatment probe by theimaging probe can cause the system to stop motion of one or both probesand generate an alert to the physician to prevent harm to the patient.In addition, it is important to prevent collisions between the roboticarms or between a robotic arm and a surgical tool or accessory, as thiscould cause injury to a patient or impact the execution of a treatmentplan. These types of collisions can be limited or prevented by acalibration procedure based on using the forward kinematics dataregarding the arms.

In some embodiments, one or more of computer vision, image recognition,or a trained machine learning model may be used to assist the system torecognize when one or both probes are too close to each other or totissue or an organ of a patient.

In these and other embodiments, stopping motion of one or both probes orchanging the position, location, or orientation of one or both probesmay be implemented by controlling one or both robotic arms.

FIG. 1 shows an exemplary embodiment of a system 400 for performingtissue resection in a patient. The system 400 may comprise a treatmentprobe 450 and an imaging probe 460. The treatment probe 450 may becoupled to a first arm 442, and the imaging probe 460 coupled to asecond arm 444. One or both of the first arm 442 and the second arm 444may comprise robotic arms whose movements may be controlled by one ormore computing devices operably coupled with the arms. The treatmentprobe 450 may comprise a device for removing target tissue from a targetsite within a patient. The treatment probe 450 may be configured todeliver energy from the treatment probe 450 to the target tissuesufficient for removing or otherwise treating the target tissue. Forexample, the treatment probe 450 may comprise an electrosurgicalablation device, a laser ablation device, a transurethral needleablation device, a water jet ablation device, or any combinationthereof. The imaging probe 460 may be configured to deliver energy fromthe imaging probe 460 to the target tissue sufficient for imaging thetarget tissue. The imaging probe 460 may comprise an ultrasound probe, amagnetic resonance probe, an endoscope, or a fluoroscopy probe, forexample. The first arm 442 and the second arm 444 may be configured tobe independently adjustable, adjustable according to a fixedrelationship, adjustable according to a user selected relationship,independently lockable, simultaneously lockable, or any combinationthereof.

The first arm 442 and the second arm 444 may have multiple degrees offreedom, for example six degrees of freedom, to manipulate the treatmentprobe 450 and the imaging probe 460, respectively. The treatment system400 may be used to perform tissue resection in an organ of a patient,such a prostate of a patient. The patient may be positioned on a patientsupport 449 such as a bed, a table, a chair, or a platform. Thetreatment probe 450 may be inserted into the target site of the patientalong an axis of entry that coincides with the elongate axis 451 of thetreatment probe. For example, the treatment probe 450 may be configuredfor insertion into the urethra of the patient, so as to position anenergy delivery region of the treatment probe within the prostate of thepatient. The imaging probe 460 may be inserted into the patient at thetarget site or at a site adjacent the target site of the patient, alongan axis of entry that coincides with the elongate axis 461 of theimaging probe. For example, the imaging probe 460 may comprise atransrectal ultrasound (TRUS) probe, configured for insertion into therectum of the patient to view the patient's prostate and the surroundingtissues. As shown in FIG. 1 , the first arm 442 and the second arm 444may be covered in sterile drapes to provide a sterile operatingenvironment, keep the robotic arms clean, and reduce risks of damagingthe robotic arms. Further details regarding the various components ofthe system 400 suitable for incorporation with embodiments as disclosedherein may be found in U.S. Pat. Nos. 7,882,841, 8,814,921, 9,364,251,and PCT Publication No. WO2013/130895, the entire disclosures of whichare incorporated herein by reference.

FIG. 2 schematically illustrates an exemplary embodiment of the system400 for performing tissue resection in a patient. The system 400comprises a treatment probe 450 and may optionally comprise an imagingprobe 460. The treatment probe 450 is coupled to a console 420 and alinkage 430. The linkage 430 may comprise one or more components of therobotic arm 442. The imaging probe 460 is coupled to an imaging console490. The imaging probe may be coupled to the second robotic arm 444, forexample. The patient treatment probe 450 and the imaging probe 460 canbe coupled to a common base 440. The patient is supported with thepatient support 449. The treatment probe 450 is coupled to the base 440with a first arm 442. The imaging probe 460 is coupled to the base 440with a second arm 444. One or both of the first arm 442 and the secondarm 444 may comprise robotic arms whose movements may be controlled byone or more computing devices operably coupled with the arms, asdescribed in further detail herein.

Although reference is made to a common base, the robotic arms can becoupled to a bed rail, a console, or any suitable supporting structureto support the base of the robotic arm.

In some embodiments, system 400 comprises a user input device 496coupled to processor 423 for a user to manipulate the surgicalinstrument on the robotic arm. A user input device 496 can be located inany suitable place, for example, on a console, on a robotic arm, on amobile base, and there may be one, two, three, four, or more user inputdevices used in conjunction with the system 400 to either provideredundant avenues of input, unique input commands, or a combination. Insome embodiments, the user input device comprises a controller to movethe end (typically referred to as the distal end) of the treatment probeor the imaging probe in response to mechanical movements of the userinput device. The end of the probe can be shown on the display 425 andthe user can manipulate the end of the probe. For example, the userinput device may comprise a 6 degree of freedom input controller inwhich the user is able to move the input device with 6 degrees offreedom, and the distal end of the probe moves in response to movementsof the controller. In some embodiments, the 6 degrees of freedomcomprise three translational degrees of freedom and three rotationaldegrees of freedom. The computing device or processor can be configuredwith instructions for the probe control to be switched between automatedimage-based guidance treatment with the energy source and treatment withthe energy source in response to user movement of the user input device,for example.

The patient is placed on the patient support 449, such that thetreatment probe 450 and ultrasound probe 460 can be inserted into thepatient. The patient can be placed in one or more of many positions suchas prone, supine, upright, or inclined, for example. In someembodiments, the patient is placed in a lithotomy position, and stirrupsmay be used, for example. In some embodiments, the treatment probe 450is inserted into the patient in a first direction on a first side of thepatient, and the imaging probe is inserted into the patient in a seconddirection on a second side of the patient. For example, the treatmentprobe can be inserted from an anterior side of the patient into aurethra of the patient, and the imaging probe can be insertedtrans-rectally from a posterior side of the patient into the intestineof the patient. The treatment probe and imaging probe can be placed inthe patient with one or more of urethral tissue, urethral wall tissue,prostate tissue, intestinal tissue, or intestinal wall tissue extendingtherebetween.

The treatment probe 450 and the imaging probe 460 can be inserted intothe patient in one or more of many ways. During insertion, each of thefirst and second arms may comprise a substantially unlockedconfiguration such that the treatment or imaging probe can be desirablyrotated and/or translated in order to insert the probe into the patient.When the probe has been inserted to a desired location, the arm can belocked. In the locked configuration, the probes can be oriented inrelation to each other in one or more of many ways, such as parallel,skew, horizontal, oblique, or non-parallel, for example. It can behelpful to determine the orientation of the probes with angle sensors asdescribed herein, in order to map the image data of the imaging probe totreatment probe coordinate references. Having the tissue image datamapped to treatment probe coordinate reference space can allow accuratetargeting and treatment of tissue identified for treatment by anoperator such as the physician.

In some embodiments, the treatment probe 450 is coupled to the imagingprobe 460 in order to align the treatment probe 450 based on images fromimaging probe 460. The coupling can be achieved with the common base 440as shown. Alternatively, or in combination, the treatment probe and/orthe imaging probe may comprise magnets to hold the probes in alignmentthrough tissue of the patient. In some embodiments, the first arm 442 isa movable and lockable arm such that the treatment probe 450 can bepositioned in a desired location in a patient. When the probe 450 hasbeen positioned in the desired location of the patient, the first arm442 can be locked with an arm lock 427. The imaging probe can be coupledto base 440 with the second arm 444, which can be used to adjust thealignment of the imaging probe when the treatment probe is locked inposition. The second arm 444 may comprise a lockable and movable armunder control of the imaging system or of the console and of the userinterface, for example. The movable arm 444 may be micro-actuatable sothat the imaging probe 460 can be adjusted with small movements, forexample a millimeter or so in relation to the treatment probe 450.

In some embodiments, the treatment probe 450 and the imaging probe 460are coupled to angle sensors so that the treatment can be controlledbased on the alignment of the imaging probe 460 and the treatment probe450. A first angle sensor 495 may be coupled to the treatment probe 450with a support 438. A second angle sensor 497 may be coupled to theimaging probe 460. The angle sensors may comprise one or more of manytypes of angle sensors. For example, the angle sensors may comprisegoniometers, accelerometers and combinations thereof. In someembodiments, the first angle sensor 495 comprises a 3-dimensionalaccelerometer to determine an orientation of the treatment probe 450 inthree dimensions. In some embodiments, the second angle sensor 497comprises a 3-dimensional accelerometer to determine an orientation ofthe imaging probe 460 in three dimensions. Alternatively, or incombination, the first angle sensor 495 may comprise a goniometer todetermine an angle of treatment probe 450 along an elongate axis 451 ofthe treatment probe. The second angle sensor 497 may comprise agoniometer to determine an angle of the imaging probe 460 along anelongate axis 461 of the imaging probe 460. The first angle sensor 495is coupled to a controller 424 of the treatment console 420. The secondangle sensor 497 of the imaging probe is coupled to a processor 492 ofthe imaging console 490. Alternatively, or in combination, the secondangle sensor 497 may be coupled to the controller 424 of the treatmentconsole 420.

The console 420 comprises a display 425 coupled to a processor system incomponents that are used to control treatment probe 450. The console 420comprises a processor 423 having a memory 421. Communication circuitry422 is coupled to processor 423 and controller 422. Communicationcircuitry 422 is coupled to the imaging console 490 via thecommunication circuitry 494 of the imaging console. Arm lock 427 ofconsole 420 may be coupled to the first arm 442 to lock the first arm orto allow the first arm to be freely movable to insert probe 450 into thepatient.

Optionally, the console 420 may comprise components of an endoscope 426that is coupled to anchor 24 of the treatment probe 450. Endoscope 426can comprise components of console 420 and an endoscope insertable withtreatment probe 450 to treat the patient.

Optionally, the console 420 may comprise one or more of modules operablycoupled with the treatment probe 450 to control an aspect of thetreatment with the treatment probe. For example, the console 420 maycomprise one or more of an energy source 22 to provide energy to thetreatment probe, balloon inflation control 26 to affect inflation of aballoon used to anchor the treatment probe at a target treatment site,infusion/flushing control 28 to control infusion and flushing of theprobe, aspiration control 30 to control aspiration by the probe,insufflation control 32 to control insufflation of the target treatmentsite (e.g., the prostate), or a light source 33 such as a source ofinfrared, visible light or ultraviolet light to provide optical energyto the treatment probe.

The processor, controller and control electronics and circuitry caninclude one or more of many suitable components, such as one or moreprocessor, one or more field-programmable gate array (FPGA), and one ormore memory storage devices. In some embodiments, the controlelectronics controls the control panel of the graphic user interface(hereinafter “GUI”) to provide for pre-procedure planning according touser specified treatment parameters as well as to provide user controlover the surgery procedure.

The treatment probe 450 may comprise an anchor 24. The anchor 24 cananchor the distal end of the probe 450 while energy is delivered toenergy delivery region 20 with the probe 450. The probe 450 may comprisea nozzle 200.

The treatment probe 450 may be coupled to the first arm 442 with alinkage 430. The linkage 430 may comprise components to move energydelivery region 20 to a desired target location of the patient, forexample, based on images of the patient. The linkage 430 may comprise afirst portion 432, a second portion 434 and a third portion 436. Thefirst portion 432 may comprise a substantially fixed anchoring portion.The substantially fixed anchoring portion 432 may be fixed to support438. Support 438 may comprise a reference frame of linkage 430. Support438 may comprise a rigid chassis or frame or housing to rigidly andstiffly couple the first arm 442 to treatment probe 450. The firstportion 432 can remain substantially fixed, while the second portion 434and third portion 436 can move to direct energy from the probe 450 tothe patient. The first portion 432 may be fixed to the substantiallyconstant distance 437 to the anchor 24. The substantially fixed distance437 between the anchor 24 and the fixed first portion 432 of the linkageallows the treatment to be accurately placed. The first portion 432 maycomprise a linear actuator to accurately position the high-pressurenozzle 200 in the energy delivery region 20 at a desired axial positionalong an elongate axis 451 of treatment probe 450.

The elongate axis 451 of treatment probe 450 generally extends between aproximal portion of the probe 450 near linkage 430 to a distal endhaving anchor 24 attached thereto. The third portion 436 can control arotation angle 453 around the elongate axis 451. During treatment of thepatient, a distance 439 between the energy delivery region 20 and thefirst portion 432 of the linkage may vary with reference to anchor 24.The distance 439 may adjust in manner 418 in response to computercontrol to set a target location along the elongate axis 451 of thetreatment probe referenced to anchor 24. The first portion of thelinkage remains fixed, while the second portion 434 adjusts the positionof the energy delivery region 20 along the axis 451. The third portionof the linkage 436 adjusts the angle 453 around the axis in response tocontroller 424 such that the distance along the axis at an angle of thetreatment can be controlled very accurately with reference to anchor 24.The probe 450 may comprise a stiff member such as a spine extendingbetween support 438 and anchor 24 such that the distance from linkage430 to anchor 24 remains substantially constant during the treatment.The treatment probe 450 is coupled to treatment components as describedherein to allow treatment with one or more forms of energy such asmechanical energy from a jet, electrical energy from electrodes oroptical energy from a light source such as a laser source. The lightsource may comprise infrared, visible light or ultraviolet light. Theenergy delivery region 20 can be moved under control of linkage 430 suchas to deliver an intended form of energy to a target tissue of thepatient.

The imaging console 490 may comprise a memory 493, communicationcircuitry 494 and processor 492. The processor 492 in correspondingcircuitry is coupled to the imaging probe 460. An arm controller 491 iscoupled to arm 444 to precisely position imaging probe 460. The imagingconsole may further comprise a display 495-1.

In order to facilitate precise control of the treatment probe and/or theimaging probe during treatment of the patient, each of the treatmentprobe and the imaging probe may be coupled to a robotic,computer-controllable arm. For example, referring to system 400 shown inFIG. 2 , one or both of the first arm 442 coupled to the treatment probe450 and the second arm 444 coupled to the imaging probe 460 may compriserobotic, computer-controllable arms. The robotic arms may be operablycoupled with one or more computing devices or processors configured tocontrol movement of the robotic arms. For example, the first robotic arm442 may be operably coupled with the processor 423 of the console 420,or the second robotic arm 444 may be operably coupled with the processor492 of the imaging console 490 and/or to the processor 423 of theconsole 420. The one or more computing devices, such as the processors423 and 492, may comprise computer executable instructions forcontrolling movement of the one or more robotic arms. The first andsecond robotic arms may be substantially similar in construction andfunction, or they may be different to accommodate specific functionalrequirements for controlling movement of the treatment probe versus theimaging probe.

Either robotic arm described above may comprise 6 or 7 or more joints toallow the arm to move under computer control. Suitable robotic arms arecommercially available from several manufacturers such as RoboDK Inc.,Kinova Inc. and several other manufacturers.

The one or more computing devices or processors operably coupled to thefirst and second robotic arms may be configured to automatically controlthe movement of the treatment probe and/or the imaging probe. Forexample, the robotic arms may be configured to automatically adjust theposition and/or orientation of the treatment probe and/or imaging probeduring treatment of the patient, according to one or more pre-programmedparameters or treatment plans. The robotic arms may be configured toautomatically move the treatment probe and/or imaging probe along apre-planned or programmed treatment or scanning profile, which may bestored in or on a memory element able to be accessed by the one or morecomputing devices or processors. Alternatively, or additionally toautomatic adjustment of the robotic arms, the one or more computingdevices may be configured to control movement of the treatment probeand/or the imaging probe in response to user inputs, for example througha graphical user interface or movable controller of the treatmentapparatus.

Alternatively, or additionally to automatic adjustment of the roboticarms, the one or more computing devices may be configured to controlmovement of the treatment probe and/or the imaging probe in response toreal-time imaging or positioning information. In some embodiments, thismay be in response to patient anatomy recognized in one or more imagescaptured by the imaging probe or other imaging source (from whichallowable and safe ranges of motion of the treatment probe and/or theimaging probe may be determined) and/or position information of thetreatment probe and/or imaging probe from one or more sensors coupled tothe probes and/or the robotic arms.

As will be described further herein, changes to the control of orconstraints on the movement of the robotic arms and/or probes may resultfrom one or more of a combination of factors. These factors include (a)the possible range of motion of the robotic arms and probes as definedor expressed in the form of an image, a maximum angular or linearseparation between elements or sections of a probe or arm, amathematical function or other mathematical representation of ageometric section (e.g., a cylinder, a conic section, a sphere orsection of a sphere, a combination of different shaped sections, etc.)representing the range of possible motion of a probe, (b) constraints orlimits on the motion of a probe “taught” to the system by a physicianwho may demonstrate an allowable range of motion of the probes before orafter the probes are inserted into a patient's body, and (c) imagescaptured during a treatment procedure that are analyzed to determinewhen movement of a probe or probes should be prevented or altered toprevent collision between the probes or harm to a patient's tissue ororgans. In some embodiments, the images may be subjected to furtherprocessing in order to determine the position or orientation of one orboth probes relative to each other or to the tissue or an organ of apatient. In some embodiments, the further processing may include one ormore of image recognition, application of a trained machine learningmodel, comparison to a database of images of the patient's organs or theorgans of others, or inputs provided by a physician.

FIGS. 3A and 3B show exemplary embodiments of a common base or mount 440for supporting one or more robotic arms of an image-guided treatmentsystem as disclosed herein. FIG. 3A shows a patient support 449comprising one or more rails 452. The patient support 449 may comprise asurgical table or a platform. One or more robotic arms associated withone or more of the treatment probe or the imaging probe may be mountedto the rails 452, such that the rails function as the common base 440.FIG. 3B shows a common base 440 comprising a floor stand 454 configuredto couple to the first robotic arm connected to the treatment probeand/or the second robotic arm connected to the imaging probe. Thefloor-stand 454 may be positioned between the patient's legs during thetreatment procedure.

FIGS. 4A and 4B illustrate an exemplary embodiment of a treatment system400 as described herein comprising a mobile base 470. FIG. 4A is a frontview and FIG. 4B is a side view of the treatment system 400. Thetreatment system 400 comprises a treatment probe 450 coupled to a firstrobotic arm 442, and an imaging probe 460 coupled to a second roboticarm 444. The first robotic arm 442 and the second robotic arm 444 eachcomprises a proximal end and a distal end, the distal end coupled to thetreatment probe 450 and the imaging probe 460, respectively, and theproximal end coupled to a common base 440 comprising a mobile base 470.The first robotic arm 442 may comprise a first arm coupling structure504 to couple to the treatment probe 450, and the second robotic arm 444may comprise a second arm coupling structure 505 to couple to theimaging probe 460. The treatment probe 450 may be coupled to the distalend of the first robotic arm 442 via an attachment device 500, which maycomprise a linkage configured to affect movement of the treatment probeas described herein (e.g., rotation, translation, pitch, etc.). Couplingof the treatment probe 450 to the first robotic arm 442 may be fixed,releasable, or user adjustable. Similarly, coupling of the imaging probe460 to the second robotic arm 444 may be fixed, releasable, or useradjustable.

The first robotic arm 442 may articulate at one or more first arm joints443. The imaging arm 444 may articulate at one or more second arm joints445. Each arm joint 443 or 445 may be operably coupled with acomputer-controllable actuator, such as a stepper motor, to affectmovement at the joint. Each arm joint 443 or 445 may comprise one of avariety of kinematic joints including but not limited to a prismatic,revolute, parallel cylindrical, cylindrical, spherical, planar, edgeslider, cylindrical slider, point slider, spherical slider, or crossedcylindrical joint, or any combination thereof. Moreover, each arm joint443 or 445 may comprise a linear, orthogonal, rotational, twisting, orrevolving joint, or any combination thereof.

The system 400 may further comprise a console 420 as described herein,which may be supported by a mobile support 480 separate from the mobilebase 470. The console 420 may be operably coupled with the mobile base470 via a power and communication cable 475, to allow control of thetreatment probe 450 coupled to the mobile base via the first roboticarm. The treatment console 420 comprises a computing device, typicallyincluding a processor and a memory having stored thereon or thereincomputer-executable instructions for execution by the processor. Whenexecuted, the instructions may cause the console to control variousmodules or functionalities of the treatment console, such as an energysource, infusion/flushing control, aspiration control, and othercomponents as described herein with reference to FIG. 2 .

The treatment console 420 may further comprise a display 425 incommunication with the processor. The display 425 may be configured todisplay, for example, one or more of: subject vital signs such as heartrate, respiratory rate, temperature, blood pressure, oxygen saturation,or any physiological parameter or any combination thereof; status of aprocedure; one or more previously taken images or sequence of images ofa treatment site from one or more views; one or more real-time images orsequence of images of the treatment site from one or more views acquiredby the imaging probe 460; a set of treatment parameters including butnot limited to a treatment mode such as cutting or coagulating, anintensity of treatment, time elapsed during treatment, time remainingduring treatment, a depth of treatment, an area or volume of thetreatment site that has been treated, an area of the treatment site thatwill be treated, an area or volume of the treatment site that will notbe treated, location information of the treatment probe 450 or theimaging probe 460 or both; treatment adjustment controls such as meansto adjust the depth of treatment, the intensity of treatment, thelocation and/or orientation of the treatment probe 450, the depth ofimaging, or the location and/or orientation of the imaging probe 460, orany combination thereof; or system configuration parameters.

The mobile base 470 may further comprise one or more computing devicesto control operation of the one or more robotic arms. For example, themobile base may comprise processors and a memory having stored thereonor therein computer executable instructions for execution by the one ormore processors. The memory may have stored thereon or thereininstructions for operating the one or more robotic arms coupled to themobile base. The processor may be operably coupled with the robotic armsvia suitable electromechanical components to affect movement of therobotic arms. For example, each of the one or more joints of a roboticarm may comprise a step motor, and the processor may be operably coupledwith the step motor at each joint to actuate the motor by a specifiedincrement in a specified direction. Alternatively, the one or morerobotic arms may be operably coupled with one or more processors of theconsole 420 or a separate imaging console (such as imaging console 490shown in FIG. 2 ), wherein the one or more console processors may beconfigured to execute instructions for controlling movement of the oneor more robotic arms, and may communicate the instructions to therobotic arms via communication circuitry (such as communicationcircuitry 422 of console 420 or communication circuitry 494 of console490 shown in FIG. 2 ). The computer executable instructions forcontrolling movement of the robotic arms may be pre-programmed andstored on a memory or may be provided by a user via one or more userinputs before or during treatment of the patient using the treatmentsystem.

The one or more computing devices operably coupled with the first and/orsecond robotic arms may be configured to control movement of the arms soas to adjust the pitch, yaw, roll, and/or linear position of thetreatment probe and/or imaging probe along the target site.

The mobile base 470 may comprise one or more user input devices toenable a user to control movement of the robotic arms under computerinstructions. For example, as shown in FIGS. 4A and 4B, the mobile basemay comprise a keyboard 474 and/or a footswitch 471, the footswitchoperably coupled with the mobile base via a footswitch cable 472. Thekeyboard 474 and the footswitch 471, independently or in combination,may be configured to control operation of the first robotic arm 442and/or the second robotic arm 444, for example via articulation of oneor both robotic arms at one or more joints. The keyboard and thefootswitch may be in communication with the one or more processorsconfigured to control movement of the robotic arms. When a user inputsinstructions into the keyboard and/or the footswitch, the userinstructions can be received by the one or more processors, convertedinto electrical signals, and the electrical signals may be transmittedto the one or more computer-controllable actuators operably coupled withthe one or more robotic arms. The keyboard and/or the footswitch maycontrol movement of one or both arms towards or away from a treatmentposition, a position of interest, a predetermined location, or auser-specified location, or any combination thereof.

Optionally, the keyboard 474 and the footswitch 471, independently or incombination, may be configured to control operation of the treatmentprobe 450 and/or imaging probe 460. For example, the keyboard 474 and/orfootswitch 471 may be configured to start, stop, pause, or resumetreatment with the treatment probe. The keyboard 474 and/or footswitch471 may be configured to begin imaging or freeze, save, or display onthe display 425 an image or sequence of images previously or currentlyacquired by the imaging probe.

The mobile base 470 and the mobile support 480 of the console 420 may beindependently positionable around a patient, supported by a patientsupport 449 such as a platform. For example, the mobile base 470,supporting the first and second robotic arms and the treatment andimaging probes, may be positioned between the patient's legs, while themobile support 480 carrying the console 420 and the display 425 may bepositioned to the side of the patient, such as near the torso of thepatient. The mobile base 470 or the mobile support 480 may comprise oneor more movable elements that enable the base or the support to move,such as a plurality of wheels. The mobile base 470 may be covered withsterile draping throughout the treatment procedure, in order to preventcontamination and fluid ingress.

FIGS. 5A-5B show an exemplary coupling between a treatment probe 450 anda first robotic arm 442. FIG. 5A shows the treatment probe uncoupledfrom the robotic arm. FIG. 5B shows the treatment probe coupled to therobotic arm. As shown, the treatment probe 450 may be coupled to therobotic arm 442 with an attachment device 500 which may comprise areusable motor pack. The treatment probe 450 may be removably coupled tothe attachment device 500. The attachment device may further comprise aconnector 502 configured to couple to the robotic arm and lock theattachment device in place. The robotic arm 442 may comprise a couplingstructure 504 disposed at the distal end of the arm, configured tolockingly receive the connector 502 of the attachment device 500. Oncethe treatment probe and the robotic arm are coupled together, movementof the treatment probe may be controlled by moving the robotic arm(e.g., by articulating one or more joints of the robotic arm undercomputer control).

In some embodiments, the treatment probe is coupled to the robotic armvia a quick release mechanism, such that the coupling between the probeand the robotic arm is capable of a quick disconnect in order to preventinjury to the patient in case the robotic arm loses position orotherwise fails to operate correctly. The treatment probe and therobotic arm may be coupled to one another in many ways such asmechanically (e.g., a broom clip) and/or magnetically. For example, inthe embodiment shown in FIGS. 5A and 5B, the coupling structure 504 maycomprise a slot 506 having a magnet 508 disposed therein, and theconnector 502 may comprise a ferromagnetic fixture configured to fitwithin the slot 506 to engage the magnet 508. The coupling structure 504may further comprise a latching mechanism 510 to selectively engage ordisengage the connector 502 with the magnet 508. For example, as shownin FIGS. 5A and 5B, the latching mechanism 510 may comprise a rotatableknob that can be rotated to affect engagement of the magnet 508 of thecoupling structure 504 with the connector 502 of the attachment device500. The latching mechanism may be automatically or manually engaged ordisengaged by a user to couple or de-couple, respectively, theattachment device 500, and hence the treatment probe 450 coupledthereto, to the robotic arm 442. In some embodiments, the couplingstructure 504 may be operably coupled with the one or more computingdevices configured to control the robotic arm, and the one or morecomputing devices may comprise instructions to release the coupling ofthe coupling structure to the probe when an error is detected in theoperation of the robotic arm.

In some embodiments, the first robotic arm 442 may be configured toautomatically locate the treatment probe 450 in response to sensorlocation data from one or more of the attachment device 500 or couplingstructure 504. The first robotic arm 442 may be operated in a “seek”mode, for example, to locate the attachment device 500. In someembodiments, the probe comprises one or more fiducial targets and therobotic arm comprises corresponding sensors of sufficient resolution andpositioning to identify the relative position of the probe in 3D space.In some embodiments, the processor is configured with instructions toseek the treatment probe or imaging probe with the mounting structureson the robotic arm while the user holds the probe steady, for examplewhen the probe has been positioned in the patient.

The sensors on the robotic arm such as the first robotic arm 442 andsensors on the probe such as the treatment probe can be arranged in manyways, for example as shown in FIG. 8B.

The processor can be coupled to the sensors near the end of the roboticarm or on the probe to dynamically update the relative location duringthe movement of the robot arm while seeking to engage the probe on thearm. The sensors on the robotic arm may comprise a plurality of sensorscomprising one or more of capacitive, capacitive displacement, doppler,inductive, magnetic, optical, radar, sonar, ultrasonic or Hall effectsensors, in order to determine relative distances between the roboticarm and the probe. In some embodiments the probe comprises a pluralityof targets and the sensors are configured to generate signals inresponse to distances from the plurality of targets. Alternatively, orin combination, the sensors can be located on the probe and the targetson the robotic arm. In some embodiments, the sensors comprise closecontact mechanical sensors to confirm docking of the probe on therobotic arm or in proximity to the arm, for example to sense theposition of the probe in relation to the robotic arm when the probe andarm are within a few millimeters of docking with each other. The closecontact mechanical sensors may comprise one or more of micro-motionswitches, whisker touch sensors, or a pin-in-hole contact switch. Insome embodiments, the probe and robotic arm comprise an integratedlocking mechanism to provide a non-movement locking engagement at thefinal position of contact. The integrated locking mechanism may compriseone or more of magnetics, electromagnetics, a latching, screw such as amulti turn latching screw or quarter turn locking screw, a vacuum, orother mechanical means of reversible attachment as will be understood byone of ordinary skill in the art.

In some embodiments, a plurality of sensors is used, such as one or moresensors for near, one or more sensors for intermediate and one or moresensors for far separation distances between the probe and the roboticarm. A coarse location sensor can be used to determine the approximatelocation of the probe, e.g. a beacon. One or more sensors can be usedfor fine location positioning of the probe in relation to the roboticarm, e.g. proximity sensors. In some embodiments, one or more markers onthe probe are used with a camera and machine vision detection of the oneor more markers.

In some embodiments, coarse location sensors may be provided which maybe an infrared (IR) beacon which enables the coarse positional spatiallocation for homing detection of the robotic arm to the probe. In somecases, a homing beacon, such as an IR beacon, allows for homing acrosslarger distances as compared to a sensor that may rely on visualrecognition of fiducials.

In some embodiments, a docking detection sensor confirms that therobotic arm has engaged or is in close proximity with a probe. As anexample, a Hall effect sensor can be used in conjunction with apermanent magnet to affect the sensors output. In some embodiments, aHall effect sensor is noise immune, non-contact, and has a consistentdetection range. Any of a number of different types of Hall sensors maybe utilized, and in many cases, the sensor functions as a simple switchand linear range measurement and detection in which the overall outputvoltage is set by the supply voltage and varies in proportion to thestrength of the magnetic field. This results in a distance measurementbetween the sensor and a locating magnet and may be used to measure thedistance between the robotic arm and the probe and aid in docking. Thesensor and beacon may be located within respective housings of therobotic arm and probe.

In some embodiments, positional sensing of the robotic arm is performedby an inertial measurement unit (IMU), which may include up to 9-axisdetection. In some cases, a 6-axis IMU can be used for motion detection,vibration detection, positional orientation information, redundancy andbackup of the primary encoder signals that may be located in the jointsof the robotic arms. The IMUs may perform a dual function of seeking aprobe for docking with the robotic arm as well as force detection andmotion compensation as described herein. The described sensors can beused in combination with any robotic arms or probes described herein.

According to some embodiments, the procedure for docking a robotic armwith a probe may comprise an IR beacon to provide coarse positional andspatial location for homing detection, fiducials on either the arm orthe probe and an optical sensor to view the fiducials which can be usedto allow fine alignment of positional location in the XY plane, and aHall effect sensor to detect Z direction proximity for docking. An IRbeacon allows for larger distance seek for the home position of therobotic arm relative to the probe. The fiducials and optical sensor mayallow for rapid, low-latency detection of the 3D location and 3Dorientation of the probe by the robotic arm. A user interface, which maybe located on the robotic arm, on the probe, or on a robotic arm controlunit, may indicate distance, position, docked status or otherinformation. In some embodiments, the user interface includes one ormore visual cues, such as LED indicators, to indicate the relativeposition and/or docking status of the arm and probe.

While the coupling mechanism shown in FIGS. 5A and 5B is described inthe context of coupling the treatment probe to the first robotic arm, asubstantially similar mechanism may also be used for coupling theimaging probe to the second robotic arm 444. For example, the couplingstructure of the second robotic arm 444 may comprise a similar couplingmechanism for engaging an attachment device connected to the imagingprobe.

FIG. 6 shows a method 600 for operating a robotic arm coupled to atreatment probe in accordance with some embodiments.

With a step 605, a treatment probe is inserted into the patient, withthe robotic arm on standby to one side of the patient, manually,semi-automatically, or automatically. For example, for a prostatictissue resection system, the treatment probe may be manually insertedinto the urethra of the patient towards the prostate. The treatmentprobe may be manipulated as it is advanced to track the tortuous path ofthe urethra, prostate, and bladder neck. After entering the urethra, thetreatment probe may be turned (e.g., by 90 degrees) before furtheradvancement through the urethral bulb. Instructions may be provided tothe user to perform such a turn, or in cases where insertion isautomatic or semi-automatic, the robotic arm may be instructed to makesuch a turn in response to image, position, and/or force feedback data.In some embodiments, the treatment probe is inserted into the patientconcurrently with or after the imaging probe, and in some instances, thetreatment probe insertion may be guided by image data from the insertedimage probe. The insertion point or location of a patient may vary, andmay include organs, the prostrate, kidney, heart, lung, liver, etc. Asmentioned, while some embodiments of the present disclosure are directedto transurethral treatment of the prostate, aspects may also be used totreat and modify other tissues and associated organs. These othertissues and associated organs include but are not limited to the brain,heart, lungs, intestines, eyes, skin, kidney, liver, pancreas, stomach,uterus, ovaries, testicles, bladder, ear, nose, mouth, soft tissues suchas bone marrow, adipose tissue, muscle, glandular and mucosal tissue,spinal and nerve tissue, cartilage, hard biological tissues such asteeth, bone, as well as body lumens and passages such as the sinuses,ureter, colon, esophagus, lung passages, blood vessels, and throat.

With a step 610, the robotic arm is coupled to the treatment probe. Auser can manually align the robotic arm coupling structure to theattachment device of the treatment probe as described herein, while therobotic arm remains in a passive or “zero-gravity” mode. The attachmentdevice and the coupling structure of the robotic arm can couple togetherto attach the robotic arm to the treatment probe. In some embodiments, arobot or robotic arm may be configured to “find” the inserted probewhile operating in an autonomous or semi-autonomous mode.

With a step 615, the allowable range of motion for the robotic arm isprogrammed. For example, a user can manually move, rotate, and angulatethe treatment probe to set the boundaries for the allowable range ofmotion of the treatment probe, while the probe is connected to therobotic arm with the robotic arm still in passive mode. The user may setthe boundaries based on a combination of cystoscopic, ultrasound, andhaptic feedback. Alternatively, the boundaries may be based on anatomysuch as anatomical models or tissue conditions. The processor operablycoupled with the robotic arm can detect and store the boundaries for theallowable range of motion, such that the robotic arm, when switched toactive mode, can use these boundaries to avoid moving outside of theallowable range of motion.

In some embodiments, a treatment probe is manually inserted within apenile urethra and placed with the distal end about 1 cm past the mediumlobe and within a bladder of the patient. The probe can be imaged, forexample with ultrasound such as a TRUS probe. The images of the probemay show the probe manually positioned near the final location in thepatient anatomy, for example about 1 cm past the median lobe within thebladder. In some embodiments, the range of motion is manually calibratedby the medical practitioner manipulating the probe parallel to an angleof initial insertion docking the treatment probe upward in the pubic orurethral arch and restricting motion to within a range from about 3 mmto about 5 mm laterally in the X plane, within a range from about 0 mmto 10 about mm downward in the Y plane. The trained motion for the Zplane (into and out of the patient) would be set to zero cm inwardtoward the patient and full extraction out of the patient. For example,a 30 cm probe could be retracted as much as 30+cm to remove it from thepatient and much less if adjusting the effective area for clinicaltreatment.

Angularly, as measured from the physician's full insertion position, therange of safe motion within the patient depends on anatomic structuressuch as tissue elasticity and bony structure. An example of angularpositioning with the fulcrum at the pelvic notch bone structure theallowable angular range of motion can be set to be within a range fromabout 0 degrees to about +/−5 degrees in the lateral X direction, withina range from about zero degrees to +/−25 degrees in the verticaldirection along a Y plane, or a combination of motions within theseranges depending on the patient anatomy, for example.

Alternatively or in addition, the boundaries for the allowable range ofmotion of the treatment probe may be automatically or semi-automaticallydetermined with one or more system processors in response to anautomated analysis of image data of the target site such as from theimaging probe or other imaging source (e.g., a cystoscope, an externalultrasound source, a CT scanner, an MRI system, a fluoroscopic imagingsystem, etc.). The image data may be generated in real-time. Forexample, the one or more system processors may be instructed torecognize anatomy (e.g., the prostate, the external sphincter, theverumontanum, the bladder neck, etc.), and in some cases the treatmentand/or imaging probes, in the image data and determine the boundariesof, or limits upon, the allowable range of motion in response.

Alternatively or in addition, the boundaries for the allowable range ofmotion of the treatment probe may be automatically or semi-automaticallydetermined with one or more system processors in response to positionand/or force feedback data of the treatment probe from one or moreposition and/or force sensors on the treatment probe and/or treatmentprobe robotic arm. For example, the one or more force sensors on thetreatment probe and/or treatment probe robotic arm can provide tissuepressure data which may indicate areas where probe advancement is moreresisted and can present risks of tissue damage.

In some embodiments, the joint sensors within the robotic arms compriseforce feedback sensors to detect force to the probe inserted intopatient. Alternatively, or in combination, sensors coupled to theprocessor can be located at one or more of the probe or at an interfacebetween the probe and the robotic arm. For example, probe sensors withinthe probe can sense pressure near the distal end of the probe. Theprocessor can be configured with instructions to adjust the distal endof the probe translationally and/or rotationally in response to thedistal pressures sensed. The sensors may comprise one or more of multiplane strain gauge elements located along the probe to sense pressuresof the probe against tissue. The processor can be configured withinstructions to implement threshold limits to avoid undesirable tissuedamage. The multiplane strain gauge elements may comprise one or more ofelectrical conductance thin film sensors, semiconductor sensors,piezoresistors, nanoparticle-based strain sensors, capacitive sensors,optical ring resonators, fiber optic sensors, or conductive fluid in anelastomer.

In some embodiments, a probe shaft comprises a spring constant andembedded strain gauges at periodic locations along the shaft to measurebending, and axial pressure at specific points along the shaft. Thesesensor measurements can be combined with the arm joint sensors. In someembodiments, the processor is configured with instructions foridentifying or determining if a source of pressure resistance exists,such as one or more of a bony constraint related to proximity to bone, atough tissue entry fulcrum, or the distal tip of the probe being forcedagainst inner anatomy tissue. Alternatively, or in combination, theprobe on the probe may comprise elastomeric tubular sheaths havingexposed “touch areas” coupled with pressure sensors reportinginformation from elements such as rings around the probe, a linear sidestructure, or button sensor elements near the distal end of the probe.

With a step 620, the robotic arm is manipulated under computer controlthrough user inputs. The user may manipulate the robotic arm motion viainputs provided to the graphic user interface of the image-guidedtreatment system (e.g., user interface software provided through thetreatment console as described herein) or other suitable user input orcontrol element, such as a joystick. For example, the user may affectone or more of rotation, translation, and/or adjustment of pitch angleof the treatment probe. While in active mode, the robotic arm may beconfigured to move only within the boundaries of allowable range ofmotion as set in step 615. The robotic arm, while in active mode, may beconfigured to retract the treatment probe from the patient, but notadvance the treatment probe into the patient, to ensure safety of thepatient; any advancement of the probe into the patient can be performedmanually by the user. During retraction of the probe, the robotic armmay be programmed to maintain the probe on a linear track so that thez-axis position of the probe remains substantially constant.

The robotic arm and the treatment probe may be manipulated undercomputer control to perform a treatment protocol, which may beautomated. In some embodiments, a tissue resection procedure isautomatically planned based on the image data from the imaging probe orother imaging source. For example, the one or more system processors maybe instructed to recognize the prostate or other relevant anatomythereof, generate a treatment protocol in response to the locations ofthe anatomy and probes, and allow the user to modify and/or accept thetreatment protocol before it is implemented by manipulating the roboticarm and/or treatment probe.

With a step 625, the robotic arm is automatically manipulated undercomputer control to adjust the position of the treatment probe. Theposition of the treatment probe may be adjusted according topre-programmed parameters, user instructions, real-time feedback (fromimaging, position, and/or force feedback data, for example), orcombinations thereof. For example, the imaging system may be configuredto detect the location of the treatment probe during treatment, forexample using “smart” image recognition based on ultrasound images ofthe target site obtained with an ultrasound imaging probe. Based on thedetected location of the treatment probe, the robotic arm may bemanipulated automatically to adjust the position and/or orientation ofthe treatment probe, in order to align the treatment probe to the targettissue of the patient and/or to the imaging probe, and/or in order tocompensate for patient movement. With a step 628, the treatment isperformed.

With a step 630, the treatment probe is uncoupled from the robotic arm.When the treatment procedure is completed, the user can disconnect thetreatment probe from the robotic arm, manually move the robotic arm tothe side, and then remove the treatment probe from the patient.

One or more steps of the method 600 may be performed with circuitry asdescribed herein, for example, one or more of a processor or a logiccircuitry of the systems described herein. The circuitry may beprogrammed to provide one or more steps of the method 600, and theprogram may comprise program instructions stored on a computer readablememory or programmed steps of the logic circuitry such as withprogrammable array logic or a field programmable gate array.

Although the above steps show a method 600 of operating a robotic armcoupled to a treatment probe in accordance with some embodiments, aperson of ordinary skill in the art will recognize many variations basedon the teachings described herein. For example, the steps may becompleted in a different order. One or more steps may be added oromitted. Some of the steps may comprise sub-steps. Many of the steps maybe repeated as often as necessary or desired.

FIG. 7 shows a method 700 for operating a robotic arm coupled to animaging probe in accordance with some embodiments.

With a step 705, an imaging probe is inserted into the patient, with therobotic arm on standby to one side of the patient, manually,semi-automatically, or automatically. For example, for an image-guidedprostatic tissue resection system, the imaging probe may comprise a TRUSprobe and may be manually inserted into the rectum of the patient. Insome embodiments, the imaging probe is inserted concurrently with orbefore the treatment probe. The imaging probe may provide one or moreimages along the transverse plane. The imaging probe may provide one ormore images along the sagittal plane which may be generated as theimaging probe (and/or an imaging transducer within the imaging probe) isadvanced and/or retracted. The transverse and/or sagittal images may becombined to generate a three-dimensional image.

With a step 710, the robotic arm is coupled to the imaging probe. Forexample, the robotic arm and the imaging probe may be coupled togetherusing a coupling mechanism substantially similar to that describedherein with reference to the treatment probe.

With a step 715, the allowable range of motion for the robotic arm isprogrammed. For example, a user can manually move, rotate, and angulatethe imaging probe to set the boundaries for the allowable range ofmotion of the imaging probe, while the probe is connected to the roboticarm with the robotic arm still in passive mode. The user may set theboundaries based on a combination of cystoscopic, ultrasound, and hapticfeedback. Note that the allowable range of motion may differ from thepossible range of motion of elements of the probes. This may be done tofacilitate a treatment, prevent a collision between the probes orrobotic arms during a treatment, and/or protect a patient from possibleharm.

In some embodiments, a probe is manually positioned near the finallocation in the patient's rectal anatomy. The range of motion ismanually calibrated by the medical practitioner manipulating the probesubstantially parallel to an angle of initial insertion, for example.The medical practitioner moves the inserted probe within a range ofallowable motion, for example an allowable range of motion withboundaries within a range from about 3 cm to about 5 cm along one ormore of the lateral X plane or the vertical Y plane. In someembodiments, the medical practitioner moves the probe along the Z plane(into and out of the patient). In some embodiments the range of motionalong the Z plane can be within a range from 0 cm inward toward thepatient (zero to avoid inadvertent robotic caused rectal damage) to fullextraction out of the patient. For example, a 10 cm probe could beretracted 10+cm to remove it from the patient. Angularly, as measuredfrom the physician's full insertion position, the range of safe motionwithin the patient depends on anatomic structures such as tissueelasticity and bony structure. An example of angular positioning of theprobe with the fulcrum at the tissue surface (or alternatively at planesdefined by bone structure), the allowable range of motion can be setfrom 0 to about +/−15 degrees, for example from about 0 to about +/−30degrees in one or more of the X or Y planes. In some embodiments, theangular boundary may comprise a combination of motions corresponding totracing a cone within these boundaries.

The processor operably coupled with the robotic arm can detect and storethe boundaries for the allowable range of motion, such that the roboticarm, when switched to active mode, can use these boundaries to avoidmoving outside of the allowable range of motion. Alternatively or inaddition, the boundaries for the allowable range of motion of theimaging probe may be automatically or semi-automatically determined withone or more system processors in response to an automated analysis ofimage data of the target site such as from the imaging probe or otherimaging source (e.g., a cystoscope, an external ultrasound source, a CTscanner, an MRI system, a fluoroscopic imaging system, etc.). The imagedata may be generated in real-time. For example, the one or more systemprocessors may be instructed to recognize anatomy (e.g., the prostate,the external sphincter, the verumontanum, the bladder neck, etc.), andin some cases the treatment and/or imaging probes, in the image data anddetermine the boundaries for the allowable range of motion in response.

Alternatively, or in addition, the boundaries for the allowable range ofmotion of the imaging probe may be automatically or semi-automaticallydetermined with one or more system processors in response to positionand/or force feedback data of the imaging probe from one or moreposition and/or force sensors on the imaging probe and/or treatmentprobe robotic arm. For example, the one or more force sensors on theimaging probe and/or imaging probe robotic arm can provide tissuepressure data which may indicate areas where probe advancement is moreresisted and can present risks of tissue damage.

With a step 720, the robotic arm is automatically manipulated undercomputer control to scan the tissue. For example, during the planning ofthe treatment procedure, the robotic arm can be pre-programmed toautomatically scan the target site to render a 3-dimensional image ofthe target site. While in active mode, the robotic arm may be configuredto move only within the boundaries of allowable range of motion as setin step 715. The robotic arm, while in active mode, may be configured toretract the treatment probe from the patient, but not advance thetreatment probe into the patient, to ensure safety of the patient; anyadvancement of the probe into the patient can be performed manually bythe user. During retraction of the probe, the robotic arm may beprogrammed to maintain the probe on a linear track so that the z-axisposition of the probe remains substantially constant.

With a step 725, the robotic arm is manipulated under computer controlthrough user inputs. The user may manipulate the robotic arm motion viainputs provided to the graphic user interface of the image-guidedtreatment system (e.g., user interface software provided through thetreatment or imaging console as described herein). For example, the usermay affect rotation, translation, and/or adjustment of pitch angle ofthe imaging probe. While in active mode, the robotic arm may beconfigured to move only within the boundaries of allowable range ofmotion as set in step 715. The robotic arm, while in active mode, may beconfigured to retract the treatment probe from the patient, but notadvance the treatment probe into the patient, to ensure safety of thepatient; any advancement of the probe into the patient can be performedmanually by the user.

With a step 730, the robotic arm is automatically manipulated undercomputer control to adjust the position of the imaging probe. Theposition of the imaging probe may be adjusted according topre-programmed parameters, user instructions, real-time feedback (fromimaging, position, and/or force feedback data, for example), or acombination thereof. For example, the imaging system may be configuredto detect the location of the treatment probe during treatment, forexample using “smart” image recognition based on ultrasound images ofthe target site obtained with an ultrasound imaging probe. Based on thedetected location of the treatment probe, the robotic arm may bemanipulated automatically to adjust the position and/or orientation ofthe imaging probe, in order to align the imaging probe to the treatmentprobe and/or in order to compensate for patient movement. With a step732, the treatment is performed.

With a step 735, the imaging probe is uncoupled from the robotic arm.When the treatment procedure is completed, the user can disconnect theimaging probe from the robotic arm, manually move the robotic arm to theside, and then remove the imaging probe from the patient.

One or more steps of the method 700 may be performed with circuitry asdescribed herein, for example, one or more of a processor or a logiccircuitry of the systems described herein. The circuitry may beprogrammed to provide one or more steps of the method 700, and theprogram may comprise computer-executable program instructions stored onor in a computer readable memory or programmed steps of the logiccircuitry such as with programmable array logic or a field programmablegate array.

Although the above steps show a method 700 of operating a robotic armcoupled to an imaging probe in accordance with some embodiments, aperson of ordinary skill in the art will recognize many variations basedon the teachings described herein. For example, the steps may becompleted in a different order. One or more steps may be added oromitted. Some of the steps may comprise sub-steps. Many of the steps maybe repeated as often as necessary or desired.

FIG. 8A illustrates a configuration of a treatment probe 450 and animaging probe 460 during treatment of a patient with the treatmentsystem as described herein. It is desirable to ensure that the treatmentprobe and the imaging probe outside of the patient body do not collideor otherwise interfere with one another during use of the system,thereby maintaining the precision of movement of the probes andsterility of the system. The robotic arms as described herein, coupledto the treatment probe and the imaging probe and configured to controltheir movement, may be configured to maintain boundaries to preventcollision or interference between the two probes. For example, one orboth of the first robotic arm coupled to the treatment probe and thesecond robotic arm 444 coupled the imaging probe may be configured tosense a distance 520 between the two probes, and maintain the distancesubstantially constant or greater than a minimum threshold value toprevent collision. Alternatively, or additionally, as described withreference to the methods shown in FIGS. 6 and 7 , the user may programan allowable range of motion for one or both of the treatment probe andthe imaging probe so as to set boundaries for the range of motion thatwould prevent collision or interference between the probes.

For example, before the robotic arms are switched to active mode, theuser may rotate one or both of the probes over a range of allowablepitch angles 525 of the probes to program the allowable range of motionfor the probes within which the two probes do not contact one another.

With additional reference to FIG. 8B, the robotic arm 442 is coupled toa motor pack 802, as described herein. The motor pack 802 may be coupledto a hand piece 804 of a probe 450. In some embodiments, one or both ofthe robotic arms coupled to the treatment probe and the imaging probemay comprise one or more feedback sensing mechanisms. For example, thefirst robotic arm 442 and/or the second robotic arm 444 may be operablycoupled with a force sensor configured to detect a compression of thetissue anterior to the treatment probe and/or imaging probe. In someembodiments, the force exerted by the imaging probe is within a rangefrom 0 to 39 Newtons exerted upward, thereby compressing the tissue toachieve visualization of the treatment probe and target tissue region.In some embodiments, the force exerted by the treatment probe is relatedto the position of the probe within the lumen such as the urethra. Insome embodiments the force is related to a fulcrum or pivot at theurethral notch and a pivoting to lift the target anatomy. These forcescan be, respectively, within a range from 0 to 98 Newtons against thebony structure and within a range from 0 to 19 Newtons on the targetanatomy, such as the prostate.

According to some embodiments, one or more X-direction force sensors810, one or more Y-direction force sensors 812, and/or one or moreZ-direction force sensors 814 may be provided on the robotic arm 442,the hand piece 804, and/or the probe 450. The one or more force sensorsmay comprise a strain gauge, a pressure sensor, or a piezo electrictransducer, for example. In some embodiments the strain gauge comprisesany of a number of configurations of a Wheatstone bridge. A Wheatstonebridge circuit converts a small change in resistance into a measurablevoltage differential, which can be equated to an applied force. Theforce sensor may be coupled to the handpiece, such as any handpieceembodiment described herein. In some instances, one or more forcesensors are operatively coupled to the imaging probe, treatment probe,or both.

In some embodiments, the circuitry for operating the force sensor isinsulated and isolated from the imaging probe and treatment probe. Thisallows the probe to satisfy any patient leakage current requirements andreduces any noise that would be picked up by the probe, thus enhancingthe signal to noise (S/N) of the force sensor. In some embodiments, thesignal wires from the force sensor may be twisted together andoptionally may be shielded to maintain signal integrity, improveimmunity, and maintain an adequate S/N ratio. The force sensor may beformed of any suitable material, and in some cases, is formed of abiocompatible material for portions of the sensor that may come intocontact with a patient before, during, or after treatment.

In some embodiments, one or more force sensors are sized to fit on orwithin the probe shaft, such as the imaging probe or treatment probeshaft. The force sensor may be configured with any suitable strainsensitivity “k,” which is a proportional factor between the relativechange of the resistance. The strain sensitivity is a figure that isdimensionless and is called the Gauge Factor (“GF”). A linear patternstrain gauge may be used to measure strain in a single direction on thehandpiece. Conductive signal wires may be bonded to the pads of thesensor which carry the signal to an input amplifier. One or more sensorsmay be bonded to one or more probes on a carrier substrate that mayinsulate the sensor from any metal of the probe, such as a metal probeshaft.

Displacement in the Z-direction of the handpiece can be detected by aspring and sensor 814. Utilizing this configuration, the entire probeassembly can be able to slide a suitable distance to provide protectionfrom a probe being driven into a tissue wall. The probe assembly may bearranged on a sliding trolley 820 which can be sprung against a simplespring to provide a constant and known force “K” spring constant.Accurate distance measurement of the handpiece, such as by displacementof the trolley, is possible over a short distance with a suitablearrangement, such as less than 2 inches. Other positional encoder linearsensors may be used in combination, or in the alternative. For example,a linear variable differential transformer (LVDT), is anelectromechanical sensor used to convert mechanical motion into avariable electrical current and can be used to measure resistance to theinsertion force of the probe. An optical encoder, or any of a number ofsuitable inductive linear encoders may also or instead be used. A sensorcan measure a force based upon an inductive linear encoder 824 and maybe arranged for non-contact to ensure high reliability. Ahigh-resolution encoder 824 may be provided for a linear resolution ofbetween about 15 micrometers for a digital encoder, to about 54micrometers, such as for an analogue encoder.

One or more sensors may be provided on one or more robotic arms tomeasure position, orientation, force, or some other parameter. In someinstances, two sensors may be part of the robotic arm assembly and canbe utilized to determine unintended movements. These sensors can beinternal encoders which may be located one or more joints of the roboticarm and may be an inertial measurement unit (IMU) 822. An IMU is anelectronic sensor device that measures and reports one or moreparameters, such as a force, an angular rate, and/or the orientation ofthe sensor, and may use a combination of accelerometers, gyroscopes,and/or magnetometers. Some IMUs that are suitable for incorporation intoone or more robotic arms may have a full-scale acceleration ranges of±2/±4/±8/±16 g (“g” values in relation to acceleration due to gravity)and a wide angular rate ranges of ±125/±250/±500/±1000/±2000/±4000degrees per second (“dps”). The IMUs can detect forces on the roboticarm and communicate the magnitude and/or direction of an external forceto the computing devices, such as a robotic control system. The one ormore IMUs 822 can provide feedback which can be used to control the oneor more robotic arms to compensate for vibration, positional awareness,and stabilization compensation.

As described herein, the robotic arm 442 can be docked with the probe450 by the use of sensors to aid in one or more of coarse positionalalignment, intermediate positional alignment and fine positionalalignment. For example, the probe may be associated with a beacon 830,such as an IR beacon, and the robotic arm 442 may carry an IR receiver832 that is able to detect an emission from the IR beacon 830 for coarsealignment. One or more alignment fiducials 834 may be associated withthe probe 450 and one or more alignment sensors 836 may be associatedwith the robotic arm 442. The alignment sensors 836 are able to detectthe position of the alignment fiducials, and thus determine the positionof the robotic arm 442 relative to the probe 450, as described herein.In some embodiments, proximity sensors such as Hall effect sensors orproximity switches are used to detect the alignment between the probeand the arm in order to engage the probe with the arm, for example tolatch the probe onto the arm when the arm has been suitably manipulatedinto position.

In some embodiments, when the treatment has been completed, the arm canbe decoupled from the probe while the user holds the probe, and the armdrawn away from the probe, for example the arm may automatically bedrawn away from the probe.

The one or more computing devices operably coupled with the robotic arms(such as the processor of the console 420 or console 490 as describedherein) may comprise instructions to control movement of the roboticarms in response to forces detected by the sensor, for example toprevent over-compression of the anterior tissue and resultant damage tothe tissue and/or the probe. In the exemplary use case of the treatmentsystem for prostatic tissue resection, the treatment probe is ideallypositioned at the anterior center of the prostate cavity of the patient,but without over compressing the anterior prostate to preventinadvertent injury to the urethra/prostate (e.g., excessive bleeding,necrosis, perforation of tissue) and/or damage to one or both of theimaging probe and the treatment probe.

Similarly, the imaging probe, which can be a TRUS probe, is ideallypositioned within the rectum of the patient with adequate anteriorcompression to view the prostate and the treatment probe, but withoutover compressing the tissue, so as to avoid inadvertent injury to therectum (e.g., bleeding or perforation of the tissue) and/or damage toone or both of the imaging probe and the treatment probe. The treatmentprobe, the first robotic arm coupled thereto, the imaging probe, and/orthe second robotic arm 444 coupled thereto may be provided with theforce sensor configured to detect anterior compression of the tissuewith the probe. The detected force level may be communicated to theprocessor operably coupled with the robotic arm and compared to athreshold value of force pre-programmed or stored in the memory of thecomputing system. If the detected force exceeds the threshold, then themovement of the robotic arm may be adjusted to move the probe away fromthe anterior tissue, thereby at least partially relieving compression ofthe anterior tissue.

Another exemplary feedback sensing mechanism may comprise positionand/or motion sensors operably coupled with the first and/or secondrobotic arm 444. The one or more computing devices operably coupled withthe robotic arms may comprise instructions to control movement of therobotic arms in response to the position and/or motion detected by thesensors, for example to adjust the position of the treatment and/orimaging probe in response to patient movement during a treatment and/orscanning procedure. Patient movement while a rigid element such as thetreatment probe or the imaging probe is positioned inside the patient'sbody could potentially cause injury to the patient and could necessitatethe removal of the probe during the movement and subsequentre-positioning of the probe.

A robotic arm that automatically adjusts the position of the probe inresponse to sensed movement of the patient can improve the safety aswell as the efficiency of the procedure. One or more position or motionsensors, such as coils and/or accelerometers, may be attached to thepatient, and the sensor may be operably coupled with the computingdevices controlling the robotic arms. The sensors may be configured togenerate small, localized electromagnetic fields or other signals tohelp determine the location and/or movement of the patient, for example.The computing device or processor can receive the detected patientmovement data, and accordingly adjust movement of the robotic arms tosubstantially match patient movement, such that the probe coupled to therobotic arm can remain within an acceptable range of positions withrespect to the tissue or patient organ. In some embodiments, theprocessor is configured to interrupt the treatment if the force to thesensor exceeds a threshold amount.

Optionally, in some embodiments, the robotic arms may be configured toautomatically move in a linked manner. For example, if a user of thesystem moves the first robotic arm, the second robotic arm 444 may beconfigured to automatically adjust its position accordingly. In theexemplary use case of the treatment system for prostatic tissueresection, the prostate of the patient may not be symmetrical inanatomy, and the user may need to adjust the position or orientation ofthe treatment probe accordingly (e.g., push the probe to a side, adjustthe pitch angle of the probe, etc.). The robotic arm coupled to theimaging probe may be configured to automatically detect adjustments madeto the robotic arm coupled to the treatment probe and make correspondingadjustments to the imaging probe position and/or orientation. Suchlinked movement of the two robotic arms may be useful for maintainingthe treatment and imaging probes at a desired positional relationshipwith respect to one another, for example with the elongate axis of thetreatment probe substantially aligned with the elongate axis of theimaging probe.

FIGS. 9A-9C schematically illustrate an alignment of a treatment probeaxis 451 with a sagittal plane 950 of an imaging probe 460. FIG. 9A is aside view of a treatment probe 450 that is inclined relative to animaging probe 460. The treatment probe 450 comprises an elongate axis451, and the imaging probe 460 comprises an elongate axis 461 thatprovides a reference for the images generated by the imaging probe. Theelongate axis 461 may at least partially define a sagittal image plane950. FIG. 9B is a top view of the treatment probe 450 substantiallyaligned with the sagittal image plane 950. When the treatment probe axis451 is substantially aligned with the sagittal image plane 950, asubstantial portion of the treatment probe is within the field of viewof the ultrasound probe and visible in the sagittal image. In someembodiments, the two probes are substantially aligned when the elongateaxes are aligned to within about 5 degrees of each other with respect toa plane perpendicular to the sagittal image plane. In some cases, withgreater angles of inclination between the probes, the treatment probewill extend transverse to the field of view of the ultrasound probe, andonly the portion of the probe within the field of view of the ultrasoundprobe will be visible in the ultrasound image.

When the probes are substantially aligned within the sagittal imageplane but inclined at an angle as shown in FIG. 9A, the treatment probeand tissue can appear rotated in the sagittal image and the acceptableamount of rotation can be greater than 5 degrees, for example. FIG. 9Cis a top view of the treatment probe 450 traversing a sagittal imageplane 950. When the imaging probe is not sufficiently aligned with thetreatment probe, the treatment probe can appear distorted in thesagittal plane image, with only a portion of the treatment probeextending through the sagittal field appearing in the image. In someembodiments, the treatment and imaging probes may comprise one or moresensors to confirm the desired alignment (parallel and/or coplanar) ofthe probes to one another. For example, the system may comprise a firstorientation sensor 473, and a second orientation sensor 476 on thetreatment probe 450 and the imaging probe 460, respectively. In someembodiments, the first orientation sensor, and a second orientationsensor 476 comprise magnetic elements, Hall effect sensors, dials,variable resistors, potentiometers, accelerometers, or any combinationthereof that may indicate the relative position and orientation of theprobes to one another.

In some embodiments, the angle of the sagittal plane of the ultrasoundimaging probe can be rotated by rotating the ultrasound imaging probeabout the elongate axis of the ultrasound imaging probe. For example, insome patients, the prostate is not symmetrical, or the urethral notch isdeformed, and imaging probe and the treatment probe can be located onopposite sides of the patient or at least offset relative to each otherwith respect to a midline of the patient, and rotation of the imagingprobe about its elongate axis can rotate the sagittal plane of theultrasound probe and bring the treatment probe and tissue treatmentregion within the field of view of the ultrasound imaging probe. Thealignment, orientation, and relative positioning of the treatment andimaging probes may continue to be monitored during a treatmentprocedure.

When the treatment probe and the imaging probe are insufficientlyaligned, the user can use images of the treatment probe obtained withthe imaging probe to align the treatment probe with the imaging probe,for example by providing user inputs into the GUI for controlling therobotic arm coupled to the treatment probe or the imaging probe.Alternatively, or additionally, the robotic arms may be programmed toautomatically adjust movements to maintain the probes in sufficientalignment, as described herein. For example, when a user adjusts theposition or orientation of the treatment probe by controlling the firstrobotic arm coupled to the treatment probe, the second robotic arm 444coupled to the imaging probe may automatically detect the adjustmentsmade to the first robotic arm and make corresponding adjustments tosubstantially match the pitch, roll, yaw, lateral and/or linear positionof the treatment probe along the treatment probe axis.

As will be described in greater detail, in some embodiments, images ofthe treatment probe obtained by the imaging probe may be used toautomatically cause a repositioning, translation or reorientation of oneor both probes to prevent a collision between the probes and/or harm toa patient's tissue or organs. In such embodiments, a computing devicemay determine that based on the images, the probes are too close to eachother or to an area of tissue or an organ. In some embodiments, acomputing device may use data or images regarding the range of motion ofone or both probes and images of the treatment probe obtained by theimaging probe (and also possibly images of tissue or organs surroundingthe imaging probe or treatment probe) to determine that a limit orconstraint should be placed on the range of possible motion or the rangeof the trained allowable motion of one or both probes. This limit orconstraint may be implemented by limiting or constraining the movementof the probes by the robotic arms, for example.

To provide automatically linked movement of the two robotic arms, acalibration step may be added to the treatment procedure wherein eacharm identifies its position with respect to the other arm. For example,each robotic arm may comprise a “target” on the arm of a known location;during the calibration procedure, the user may manipulate the first armto touch the target located on the second arm with the first armcoupling structure, and manipulate the second arm to touch the targetlocated on the first arm with the second arm coupling structure.Automatically linking movement of the two robotic arms can thusfacilitate the treatment procedure by eliminating the need for the userto separately adjust the movement of a second arm after moving a firstarm. In addition, the linked movement of the two arms can aid inimproving safety and efficiency of the treatment procedure in case thepatient moves while the probes are inserted into the patient's body, asdescribed herein.

Optionally, in some embodiments, the robotic arm coupled with thetreatment probe may be configured to move the treatment probe along apre-programmed treatment profile for performing treatment of the targetsite. For example, the treatment profile may comprise a tissue resectionprofile of the target site, which may be programmed by the user of thetreatment system and stored in a memory of the one or more computingdevices operably coupled with the robotic arm. Further details regardingautomated treatment using programmed treatment profiles may be found inPCT Publication No. WO2013/130895, previously incorporated herein byreference.

Optionally, in some embodiments, the robotic arm coupled with theimaging probe may be configured to move the imaging probe along apre-programmed imaging profile for generating a 3-dimensional renderingof the target site, before and/or during treatment with the treatmentprobe. A 3-dimensional image of the target site may be derived from abiplanar imaging probe by: 1) rotating the imaging probe in place withthe imaging probe capturing sagittal view images of the target site,then interpolating the sagittal view images, or 2) translating theimaging probe across the target site (along the z-axis of the probe)with the imaging probe capturing transverse view images of the targetsite, then interpolating the transverse view images. To improve theefficiency of 3D image rendering and the resolution of the resultant 3Dimages, the robotic arm may be configured to rapidly scan the targetsite along a pre-programmed imaging profile, and the 3D image may begenerated using software to render a 3D image of the treatment site insubstantially real-time. The pre-programmed imaging profile may bestored on or in a memory of the one or more computing devices, and maycomprise a plurality of sagittal view scans taken at predetermined timeintervals while the imaging probe rotates in place, and/or a pluralityof transverse view scans taken at predetermined time intervals while theimaging probe translates across the target site (along the z-axis orelongate axis of the imaging probe).

The automatic, computer-controlled scanning of the target site with theimaging probe using the robotic arm can also be used to generate usefulinformation regarding the target site for additional treatment. Forexample, the imaging probe may be configured to perform a color/Dopplerscan of the target site after a resection procedure, in order to locatebleeding sites within the target site that require hemostasis. Theimaging probe may also be used to monitor or examine a location in apatient's body after (or as part of) other types or procedures,including planning tissue removal, treatment profiles, or monitoringduring and after a procedure such as a colonoscopy and associatedbiopsy.

In some embodiments, the Doppler ultrasound image shows blood movingaway from the ultrasound probe as blue and blood moving toward theultrasound probe as red. In some embodiments, the tissue resectionprofile can be adjusted prior to tissue resection so as to decrease andin some instances avoid resection of blood vessels present in theDoppler ultrasound image. For example, the ultrasound image may comprisea 3D ultrasound image and a 3D resection profile adjusted to decrease oravoid blood vessels.

FIG. 10 illustrates the identification of high blood perfusion sites 810from an ultrasound image 800 of a tissue 805 of a patient. As describedherein, the robotic arm coupled to the imaging probe may beautomatically moved to obtain scans from the imaging probe while theimaging probe operates in Doppler imaging mode. The high blood perfusionsites 810 can be identified from the resultant Doppler scan images,based on the detection of blood flowing closer to or farther away froman imaging plane of the imaging probe. In some cases, the high bloodperfusion sites 810 comprise bleeding sites, and based on the Dopplerinformation, the user can efficiently locate and treat the bleeding, forexample by using focal cautery or hemostatic agents such as gels andmatrices. This can reduce bleeding, cautery time and heat or otherpotentially negative effect on the tissue. The high blood perfusionsites 810 may also, in some cases, comprise abnormal or even canceroustissue growths. These areas may be flagged or identified for subsequenttreatment. For example, normal tissue may be resected around abnormaltissue to leave islands of abnormal tissue that are later treated suchas with local drug delivery. In some embodiments, the robotic arms maybe configured to automatically apply a cauterization tool (RF or laserfor example) to treat an area of tissue that is bleeding based upon thedata received form the color Doppler imaging.

The 3-dimensional scan of the target site using the imaging probe mayalso be used to identify tissue anomalies at the target site, such astumors. For example, tumors may be identified from the images of thetarget site obtained with the automated scanning of the target site withthe imaging probe, based on differences between hyperechoic andhypoechoic areas of the imaged tissue. Robotically scanning of thetarget site can improve the speed of image analysis and therefore theaccurate detection of tissue anomalies. In addition, the imaging probemay be operated in Doppler imaging mode during the automated scanning toidentify regions of higher blood flow, which can correspond to locationsof potential cancer. Biopsies may be performed at the identified regionsof tissue to improve the detection of cancer.

The imaging probe may also be used to monitor or examine a location in apatient's body after (or as part of) other types or procedures,including planning tissue removal, treatment profiles, or monitoringduring and after a procedure such as a colonoscopy and associatedbiopsy.

FIG. 11 illustrates a system 2500 for one or more of locating a probe,calibrating a probe, or training a system with calibrated probemovements. In some embodiments, a calibration device 2502 comprisesreceptacles to receive the treatment probe 450 and the imaging probe460. The receptacles are sized and shaped to receive the probes and toallow the probes to move into positions that may be used during surgery.The positions of the arms and probes can be monitored during thecalibrated movement prior to placement of the probes in the patient.

In some embodiments, the processor is configured with instructions toenable the system to receive or “learn” from mechanical movements of theprobe to establish one or more boundaries or constraints on probepositioning, orientation or movement. This may be done, for example forpurposes of training the system to avoid collisions between probes,between a probe and a robotic arm, or between robotic arms. The teachingor training process may serve to constrain or limit the possible rangeof motion of a probe or probes to an allowable range of motion. In someembodiments, the processor is configured to implement a “teachingsession” or training session to establish the boundaries or limits on arange of motion, for example, prior to placing one or more of the probeswithin the patient. During this teaching session a sterile protectivecalibrated guide 2502, also referred to as a calibration device, can beprovided and the imaging probe 460 can be inserted therein and be usedto measure geometric position data for incorporation into a positionaldatabase of the robotic arm.

In some embodiments, this guide comprises one or more of a capture lumen2504 for receiving the imaging probe 460, a touch point 2506 foridentifying the tip of the treatment probe 450, one or more dual notchstructures 2508, 2510 for identifying the linear shaft location relativeto the imaging probe 460, or a planar surface identifying ‘do not cross’anatomical planes. Alternatively, or in combination, a plurality ofcameras and machine vision software instructions can be used to measurethe probe positions in 3D space relative to their respective origins andcreate a database of allowable relative positions between the twoprobes.

A calibration device 2502 may be sterile and provided with features thatenable positioning onto a first probe 460 and placement for calibrationof second probe 450 relative to the first probe 460. A capture lumen2504 or open structure provides one way to position first probe 460 intoa known position and orientation. The first probe 460 may be movedwithin the capture lumen 2504 with controlled depth of placement intothe calibration device 2502 and an envelope of its spatial boundary,e.g., a bounding volume or representation of its allowed range ofmotion, may be created and saved to a database.

In some embodiments, the calibration device 2502 includes a tip locationpocket 2506 to detect contact with the tip of the second probe 450. Afirst notch structure 2508 provides a guide for the shaft of the secondprobe 450 as the second probe 450 is advanced to the touch point 2506.The combination of the first notch structure 2508 and the touch point2506 thus provides an instructional path for placement of the secondprobe 450, the positions of which can be stored in the positionaldatabase, which also stores the relative locations of the first probe460 and the second probe 450.

With the tip of a second probe in the tip location pocket of thecalibration device 2502 the shaft of the second probe can be positionedrelative to the shaft of the first probe and a signal can be sent to aprocessor to note the positions of both robotic arms holding the firstprobe and second probe.

Similarly, the shafts of the first probe 460 and the second probe 450can be moved to another spatial orientation relative to each other, suchas by advancing the second probe 450 along the second notch structure2510 and a calibration signal can be sent to the processor to store therelative position of the first probe and second probe.

Additionally, the calibration device 2502 can be configured to accept asecond probe feature to detect and determine a rotational assurance ofthe second probe 450 and, similarly, the rotational position of thefirst probe 460 which may be used to align the treatment probe nozzlerelative to both a transverse and sagittal plane of an ultrasound probe,for example.

The calibration device 2502 thus may provide a secure physical captureregion to assure simple placement and docking of a probe tip against thecalibration device 2502, the position and orientation of which can bestored in a spatial database to teach the robotic arm controller systeman acceptable spatial envelope of relative position and orientation ofthe first probe 460 with respect to the second probe 450.

The methods and apparatus disclosed herein can be configured in manyways and may comprise fiducials and a processor configured withinstructions to provide navigation and surgical guidance to a user suchas a surgeon. For example, one or more of the imaging probe 460 (e.g.,TRUS probe), the treatment probe 450, the proximal end of the treatmentprobe 450, the proximal end of the imaging probe 460, or the robotic armmay comprise navigation fiducials. These navigational fiducials can bedetected with sensors to provide position and orientation information ofthe treatment probe 450 and imaging probe 460 relative to the patientand a fixed reference frame such as a base as described herein. Thefiducials may comprise reflective structures, energy emittingstructures, coils, magnets or visual references, for example. Thesefiducials can provide positional information to the computing navigationsystem to inform a user of errant motion. The positional information canbe used to measure and control the location of the treatment and imagingprobes and movement. The positional information can also be shown on adisplay visible to a user. The processor may comprise instructions toshow treatment fiducials on a display in relation to target locations ona patient and register real time images of the patient with the targettreatment profile in real time, for example.

As described herein, the positioning of the elements of the system, bothwith respect to a patients' tissue and organs, and with respect to eachother is of great importance for the safe and effective performance of aprocedure by a physician. For example, it is important that the roboticarms not collide with each other and that the probes not collide witheach other when placed inside a patient. This means that the absoluteand relative location, positioning and orientation of both the roboticarms and probes is preferably monitored and able to be limited orconstrained to prevent harm. In some embodiments, this can beaccomplished by defining protection regions or zones, defining exclusiveoperating or treatment areas, establishing “virtual” walls or featuresto constrain the motion or positioning of a probe, etc.

As described herein, the monitoring and constraining of the location,position, orientation, and motion of the robotic arms and probes may beaccomplished by one or by a combination of processes that will bedescribed. These processes may generally be referred to as layers ordegrees of constraint and include (1) the possible or potential range ofmotion of the elements of a probe or probes, (2) constraints on thepossible range of motion introduced by a physician during a training orteaching process and thereby defining an allowable range of motion, and(3) constraints or limitations resulting from the interpretation ofimages and/or other data obtained during a procedure that indicate apotential risk of collision or harm to a patient.

In some embodiments, the location, positional or orientation informationis used to monitor relative motion and as a feedback loop forcontrolling intentional motion or responding to unintentional motion.

FIG. 12 illustrates a system 2600 comprising an arm 2610 coupled to asheath 2620, a robotic arm 2630 coupled to a treatment probe 2640, andan arm 2670 coupled to an ultrasound probe 2680. The arms are coupled toa base 2690, which may comprise any suitable base as described herein,such as a crossbar coupled to rails of a patient support, for example.The arm 2610 may comprise any arm as described herein, and may comprisea robotic arm, or a manually adjustable arm configured to lock intoposition, for example. The sheath 2610 is configured for insertion intoa lumen of the patient such as a urethra and may comprise a stiff sheathor a flexible sheath, for example. The robotic arm 2630 may comprise anysuitable robotic arm as described herein. The treatment probe 2640 maycomprise any suitable treatment probe as described herein. The arm 2670may comprise any suitable arm as described herein, an may comprise amanual lockable arm or a robotic arm as described herein. The ultrasoundprobe 2680 may comprise any suitable ultrasound probe as describedherein, for example a TRUS probe. The robotic arms, treatment probe andultrasound probe are operatively coupled to a processor as describedherein.

FIG. 13 illustrates a robotic arm 2630 coupled to a treatment probe 2640and an arm 2610 coupled to a sheath 2620 as in FIG. 26 . The sheath 2620is coupled to arm 2610. In some embodiments, the sheath 2620 comprisesan irrigation lumen 2622 extending to one or more openings 2624 toirrigate the surgical site. The irrigation lumen can be connected to asource of irrigation fluid such as saline. The sheath may comprise alumen 2626 sized to receive the treatment probe. The lumen 2626comprises a proximal opening 2625 and extends to a distal opening 2627.In some embodiments, the sheath 2620 comprises an aspiration channel2629 extending to an opening into lumen 2620 to fluidically couple thelumen 2626 to an aspiration pump to remove resection products. Thetreatment probe 2640 is coupled to a source of energy as describedherein such as a laser, water pump, or electrical source, and comprisesan energy release structure such as nozzle, optical fiber end, aperture,or electrode to direct energy toward the tissue. The treatment probe isconfigured to translate 2646 and rotate 2648 energy 2644 from thetreatment probe. An endoscope 2650 extends into the sheath. Theendoscope comprises a viewing port such as a viewing port of anendoscopic camera 2652, which is configured to translate 2654. Theendoscope is coupled to a video display to view the treatment probe andtreatment site with the endoscope.

A coupling 2700 is coupled to an end portion of the robotic arm 2630.The coupling 2700 comprises one or more engagement structures 2710 tocouple to the end portion of the robotic arm. The robotic arm 2630comprise one or more corresponding engagement structures 2712 to connectto the coupling 2700 to the robotic arm. In some embodiments, thecoupling 2700 comprises internal structures such as linkages andactuators as described herein to translate one or more of the treatmentprobe, the endoscope, the irrigation lumen or the aspiration lumenrelative to the robotic arm. In some embodiments the coupling 2700 isconfigured to rotate the treatment probe independently of the endoscope,the irrigation lumen and the aspiration lumen. In some embodiments, thecoupling 2700 comprises a structure to receive a treatment probe anddefine an orientation of the treatment probe with respect to thecoupling. The structure to receive the treatment probe may comprise oneor more of an aperture or a channel coupled to the linkage, for example.In some embodiments, the coupling 2700 comprises an engagement structureto couple to an end portion of a robotic arm to establish an orientationof the treatment probe with respect to the end portion of the roboticarm.

In some embodiments, one or more of the arm or the sheath comprises asensor 2750 to determine the orientation of the sheath when placed inthe patient. In some embodiments, the robotic arm 2752 comprises anorientation sensor 2752 to determine the orientation of the treatmentprobe 2640 coupled to the robotic arm. Alternatively, or in combinationwith the sensors, the joint states of the robotic arm 2630 can be usedto determine the orientation of the treatment probe, and the jointstates of the arm 2610 can be used to determine the orientation of thesheath.

In some embodiments, the treatment probe comprises an elongate axis andthe sheath comprises an elongate axis to receive the treatment probe.

The system can be configured in many ways to treat the patient in manyways. In some embodiments, the sheath is sized and shaped for insertioninto the patient. The sheath comprises an elongate axis, and an arm iscoupled to the sheath. The treatment probe comprising an energy sourceand an elongate axis. The treatment probe sized and shaped for insertioninto a lumen of the sheath. The robotic arm is coupled to the treatmentprobe and configured to align the elongate axis of the treatment probewith the elongate axis of the sheath and to advance the treatment probeinto the sheath. The robotic arm coupled to the treatment probe isconfigured to align the axis of the treatment probe with the axis of thesheath prior to advancing the treatment probe into the sheath.

In some embodiments, the robotic arm comprises a sensor to determine anorientation of the treatment probe and the sensor comprises one or moreof an accelerometer, a gyroscope, or an inertial measurement unit (IMU).Alternatively, or in combination, the arm coupled to sheath comprises asensor to determine an orientation of the sheath. The sensor maycomprise one or more of an accelerometer, a gyroscope, or an IMU.

In some embodiments, sheath comprises a proximal opening to receive thetreatment probe and a distal opening and the treatment probe comprises alength sufficient to extend to at least the distal opening. In someembodiments, the treatment probe is dimensioned for the energy source toextend to at least the distal opening when the treatment probe has beenadvanced into the sheath.

In some embodiments, the energy source extends to at least the distalopening with a gap between an end portion of the robotic arm and thesheath.

Although reference is made to the coupling structure rotating thetreatment probe, in some embodiments robotic arm 2630 is configured torotate the treatment probe.

The processor can be coupled to one or more of the arm 2610, the arm2630, or the arm 2720. In some embodiments, processor configured withinstructions to advance the treatment probe into the sheath, which canfacilitate the alignment of the treatment probe with the sheath. In someembodiments, the processor is configured to align the elongate axis ofthe treatment probe with the elongate axis of the sheath. In someembodiments, the processor is configured with instructions to receive aninput indicating that the elongate axis of the treatment probe has beenaligned with the elongate axis of the sheath and to advance thetreatment probe along the elongate axis of the treatment probe inresponse to the input. The input may comprise a user input, or the inputmay comprise an input from sensor data. In some embodiments, the armcoupled to the stiff sheath comprises a sensor operatively coupled tothe processor to determine an orientation of the sheath, and theprocessor is configured with instructions to orient the treatment probewith the sheath in response to the orientation of the stiff sheathmeasured with the sensor. In some embodiments, the robotic arm comprisesa sensor to determine an orientation of the treatment probe.Alternatively, or in combination, the orientation of the treatment probecan be determined from the joint states of the robotic arm. In someembodiments, the orientation of the sheath is determined from jointstates of the arm coupled to the stiff sheath.

FIG. 14A illustrates a coupling 2700 to couple a robotic arm 2630 to atreatment probe 2640. In some embodiments, the coupling 2700 isconfigured to couple the treatment probe 2740, the endoscope 2650, anirrigation lumen 2812 and an aspiration lumen 2814 to the robotic arm.Each of these lumens may be defined by an elongate tube defining thelumen. In some embodiments, the irrigation lumen and the aspirationlumen comprise lumens of a dual lumen tube such as a catheter.Alternatively, the irrigation lumen and the aspiration lumen maycomprise separate catheters.

FIG. 14B illustrates movements of the treatment probe 2640, theendoscope 2650, the irrigation lumen 2812 and the aspiration lumen 2814provided by the coupling as in FIG. 28A. The irrigation lumen 2812extends to an opening 2813 to release an irrigation fluid.

The aspiration lumen 2814 extends to an opening 2814 to receiveresection products. The sheath 2620 is sized to receive these lumens andthe corresponding structures defining the lumens, e.g. tubes. The sheath2620 is sized to receive the treatment probe. In some embodiments, thesheath 2620 is sized to receive the endoscope 2650.

The coupling 2700 can be configured in many ways to move one or more ofthe treatment probe, the endoscope, the irrigation lumen or theaspiration lumen. In some embodiments, the coupling connects to therobotic arm 2630 and the robot arm provides motion to the treatmentprobe. For example, the robotic arm can be configured to rotate thetreatment probe. Alternatively, or in combination, the robotic arm canbe configured to rotate and translate the treatment arm.

In some embodiments, the coupling 2700 is configured to rotate thetreatment probe. For example, the coupling can be configured to rotate2648 the treatment probe. The robotic arm can be configured to translate2646 the treatment probe while the coupling 2700 rotates the treatmentprobe. In some embodiments, the endoscope 2750 is configured totranslate 2654 with the treatment probe. In some embodiments, theirrigation lumen and the aspiration lumen are configured to translatewith the treatment probe.

In some embodiments, the coupling 2700 is configured to provideindependent translational movement to the treatment probe and one ormore of the endoscope, the irrigation lumen, or the aspiration lumen. Insome embodiments, the coupling is configured to provide independenttranslation movement to the treatment probe, the endoscope, and one ormore of the irrigation probe or the aspiration probe.

FIG. 15 illustrates a method 2900 of treatment, in accordance with someembodiments.

At a step 2910, an orientation of the sheath is determined. Theorientation of the sheath can be determined from one or more sensorscoupled to the sheath, such as an orientation sensor on the arm coupledto the sheath or from the joint states of the arm coupled to the sheath.

At a step 2920, an orientation of the treatment probe is determined. Theorientation of the treatment probe can be determined from one or moresensors coupled to the treatment probe, such as an orientation sensor onthe arm coupled to the treatment probe or from the joint states of thearm coupled to the treatment probe.

At a step 2930, the elongate axis of the treatment probe is aligned withthe elongate axis of the sheath. This alignment can be performedmanually. Alternatively, the processor can be configured withinstructions to align the elongate axis of the treatment probe with theelongate axis of the sheath.

At a step 2940, an input is received indicating that the elongate axisof the treatment probe has been aligned with the elongate axis of thesheath. This input may comprise a user input based on visualization oran input from sensor data, or a combination thereof.

At a step 2950, the treatment probe is advanced along the elongate axisof the sheath in response to the input.

FIG. 16 illustrates a side view of a handpiece or treatment probe 1600and shows an example range of motion (ROM) 1622 about a ROM origin orpivot point 1610 of the probe for the distal end of the probe from thatperspective, in accordance with some embodiments.

As shown in the figure, a treatment probe 1600 may comprise a handle1602 and a wand or extension 1604 extending from the handle to a distalend 1606 of the probe. The wand or extension may comprise two segments(identified as “segment 1” 1607 and “segment 2” 1608 in the figure),with segment 1 extending from the end of the handle to a point orlocation about which the distal end may rotate or otherwise move(referred to as an origin or pivot point 1610 herein), and segment 2extending from the pivot point to the distal end of the probe.

As shown, a superior angle 1612 may be defined between the axis of theprobe 1611 and an upper boundary of the probe range of motion 1622. Insome embodiments, the superior angle may vary between 50 and 60 degrees,for example 55 degrees. An inferior angle 1614 may be defined betweenthe axis 1611 of the probe and a lower boundary of the probe range ofmotion 1622. In some embodiments, the inferior angle may vary between 20and 40 degrees, for example 30 degrees. The figure also indicatesdistances between the axis 1611 of the probe and the boundaries of therange of motion 1622. In some embodiments, the distance 1618 between theprobe axis 1611 and the upper boundary of the range of motion 1622 mayvary between 80 and 100 mm, for example 87 mm. In some embodiments, thedistance 1619 between the probe axis 1611 and the lower boundary of therange of motion 1622 may vary between 50 and 60 mm, for example 55 mm.In some embodiments, the distance 1620 between the pivot point 1610 andthe distal end 1606 of the probe may vary between 90 and 120 mm, forexample 105 mm.

The approximately conical section 1622 shown in the figure (representingthe Possible Range of Motion) is the envelope or region within which thedistal end of the probe may move about the origin (pivot) point prior toapplication of any further constraints or limitations. Note that in thisexample, the range of motion or envelope within which the distal end maymove when viewed from this perspective is not symmetrical.

FIG. 17 illustrates the treatment probe 1600 of FIG. 16 and shows anexample of a possible range of motion (ROM) 1702 for the distal end 1606of the probe, in accordance with some embodiments. The figure alsoillustrates a possible range of motion 1704 for the probe under thecontrol of a robotic arm about the pivot point 1708, where this pointrepresents the location on the probe wand or extension 1604 beyond whichthe probe is inserted into a patient's body. The figure indicatesdistances between the axis of the probe 1611 and the boundaries of therange of motion for the probe under control of the robotic arm 1704. Insome embodiments, the distance 1710 between the probe axis 1611 and theupper boundary of the range of motion 1704 may be vary between 70 and 80mm, for example 75 mm. In some embodiments, the distance 1711 betweenthe probe axis 1611 and the lower boundary of the range of motion 1704may vary between 110 and 130 mm, for example 119 mm. In someembodiments, the distance 1712 between the outer edge of the range ofmotion under robotic control 1704 and the outer edge of the range ofmotion of the distal end 1702 may vary between 225 mm and 275 mm, forexample 247 mm.

As examples, repositioning or other factors that may impact the (safe)range of motion of the distal end of the treatment probe may be due toone or more of (a) the specific treatment area involved, (b) thepatient's anatomy and differences in tissue and organ sizes and shapesbetween patients, (c) the patient's physical size, (d) the patient'sposition or orientation for the treatment, or (e) the patient's healthcondition or prior medical history. These possible reasons for a changein the range of motion of the treatment probe emphasize the importanceof preventing collisions or harm to the patient tissue and organs usingthe approaches described herein.

FIG. 18 illustrates a top view of the handpiece or treatment probe 1600of FIG. 16 and shows an example range of motion 1802 about a range ofmotion origin (pivot) point 1804 of the probe for the distal end 1606 ofthe probe from that perspective, in accordance with some embodiments.

As shown, a first side angle 1806 may be defined between the axis 1611of the probe and an upper boundary of the probe range of motion 1802. Insome embodiments, the first side angle may vary between 40 and 50degrees, for example 45 degrees. A second side angle 1807 may be definedbetween the axis 1611 of the probe and a lower boundary of the proberange of motion 1802. In some embodiments, the second side angle mayvary between 40 and 50 degrees, for example 45 degrees. The figure alsoindicates distances between the axis of the probe and the boundaries ofthe range of motion. In some embodiments, the distance 1808 between theprobe axis 1611 and the upper boundary of the range of motion 1802 maybe vary between 70 and 80 mm, for example 76 mm. In some embodiments,the distance 1809 between the probe axis 1611 and the lower boundary ofthe range of motion 1802 may vary between 70 and 80 mm, for example 76mm. In some embodiments, the distance 1810 between the pivot point 1804and the distal end of the probe 1606 may vary between 90 and 120 mm, forexample 105 mm. The approximately conical section 1802 shown in thefigure (representing the Possible Range of Motion) is the envelope orregion within which the distal end 1606 of the probe may move about theorigin (pivot) point 1804 prior to application of any furtherconstraints or limitations. Note that in this example, the range ofmotion or envelope within which the distal end may move when viewed fromthis perspective is symmetrical.

FIG. 19 illustrates the treatment probe 1600 of FIG. 18 and shows anexample of a possible range of motion (ROM) 1902 for the distal end 1606of the probe, in accordance with some embodiments. The figure alsoillustrates a possible range of motion 1904 for the probe under thecontrol of a robotic arm about the pivot point 1906, where the pivotpoint represents the location on the probe wand or extension 1604 beyondwhich the probe is inserted into a patient's body. The figure indicatesdistances between the axis of the probe 1611 and the boundaries of therange of motion 1904 for the probe under control of the robotic arm. Insome embodiments, the distance 1908 between the probe axis 1611 and theupper boundary of the range of motion 1904 may be vary between 90 and110 mm, for example 104 mm. In some embodiments, the distance 1909between the probe axis 1611 and the lower boundary of the range ofmotion 1904 may vary between 90 and 110 mm, for example 104 mm. In someembodiments, the distance 1910 between the outer edge of the range ofmotion under robotic control 1904 and the outer edge of the range ofmotion of the distal end 1902 may vary between 225 mm and 275 mm, forexample 247 mm.

FIG. 20 illustrates a side view of an imaging probe 2000 and an exampleof a range of motion 2002 for the distal end 2004 of the probe about apivot point 2006 from that perspective, in accordance with someembodiments. As shown in the figure, an imaging probe 2000 may comprisea handle 2001 and a wand or extension 2003 extending from the handle tothe distal end of the probe. The wand or extension 2003 may comprise asegment extending from a pivot point 2006 to the distal end 2004 of theprobe.

As shown, a superior angle 2008 may be defined between the axis 2010 ofthe probe and an upper boundary of the probe range of motion 2002. Insome embodiments, the superior angle may vary between 40 and 50 degrees,for example 45 degrees. An inferior angle 2009 may be defined betweenthe axis 2010 of the probe and a lower boundary of the probe range ofmotion 2002. In some embodiments, the inferior angle may vary between 5and 15 degrees, for example 10 degrees. The figure also indicatesdistances between the axis of the probe 2010 and the boundaries of therange of motion 2002. In some embodiments, the distance 2012 between theprobe axis 2010 and the upper boundary of the range of motion 2002 maybe vary between 110 and 150 mm, for example 130 mm. In some embodiments,the distance 2013 between the probe axis 2010 and the lower boundary ofthe range of motion 2002 may vary between 30 and 50 mm, for example 40mm. In some embodiments, the distance 2014 between the pivot point 2006and the distal end 2004 of the probe may vary between 150 and 200 mm,for example 180 mm. Note that as viewed from this perspective the rangeof motion or envelope within which the distal end of the probe may moveis not symmetrical.

FIG. 21 illustrates a top view of the imaging probe 2000 of FIG. 20 andan example of a range of motion 2002 for the distal end 2004 of theprobe about a pivot point 2006 from that perspective, in accordance withsome embodiments. As shown, a first side angle 2102 may be definedbetween the axis 2010 of the probe and an upper boundary of the proberange of motion 2002. In some embodiments, the first side angle may varybetween 10 and 20 degrees, for example 15 degrees. A second side angle2103 may be defined between the axis 2010 of the probe and a lowerboundary of the probe range of motion 2002. In some embodiments, thesecond side angle may vary between 10 and 20 degrees, for example 15degrees. The figure also indicates distances between the axis of theprobe 2010 and the boundaries of the range of motion 2002. In someembodiments, the distance 2104 between the upper boundary of the rangeof motion and the lower boundary may be vary between 100 and 140 mm, forexample 120 mm. In some embodiments, the distance 2106 between the pivotpoint 2006 and the distal end 2004 of the probe may vary between 150 and200 mm, for example 180 mm. Note that as viewed from this perspectivethe range of motion or envelope within which the distal end of the probemay move is symmetrical.

FIG. 22 illustrates a side view of a treatment probe 1600 and an imagingprobe 2000 and shows the respective ranges of motion of the distal endof each probe overlaid with each other from that perspective, inaccordance with some embodiments. In the figure, the probes are separatebut colinear or substantially parallel to each other with the pivotpoint of the treatment probe positioned in front of (offset from) thepivot point of the imaging probe, as indicated by the distancerepresented by the separation of the pivot points of the probes 2202.

The longitudinal and lateral separation between the probes may vary orbe varied as needed for a specific patient anatomy and treatment. Forexample, in some embodiments, the longitudinal separation 2202 of thepivot points (or fulcrums) of the two probes may vary between 25 and 75mm, for example 50 mm. The lateral separation 2203 of the twosubstantially parallel probes may vary between 25 and 75 mm, for example50 mm. As shown in the figure, the possible range of motion for thetreatment probe 2204 is of a different shape and dimensions than that ofthe imaging probe 2206, as viewed from this perspective. Thelongitudinal and/or lateral separation of the two probes may be setinitially and then modified by a physician based on patient anatomy, thespecific treatment being performed, a CT or MRI scan, a pre-programmedprofile for a treatment or patient, etc.

The relative positioning of the distal ends of the two probes shown inthe figure is an example of how the two probes may be positioned whenused for a treatment. This example of the relative positioning mayresult from a physician inserting each probe into a patient and thenrepositioning one or both probes prior to a treatment. This example ofthe relative positioning may also result from a robotic arm moving oneor both probes after the probes are inserted into a patient. Note thatin some embodiments, the system may be used to calibrate or pre-programthe movements of the robotic arms to ensure that the two probes don'tcollide or come within a specified distance of each other (even thoughtheir range of motion (ROM) may intersect or overlap).

FIG. 23 illustrates a top view of the treatment probe 1600 and imagingprobe 2000 of FIG. 22 and shows the respective ranges of motion of thedistal end of each probe overlaid with each other from that perspective,in accordance with some embodiments. As with FIG. 22, in FIG. 23 theprobes are separate but colinear or parallel to each other with thepivot point of the treatment probe positioned in front of (offset from)the pivot point of the imaging probe. Note that in the embodiment shown,the distal ends 2302 of the two probes are also offset. Note also thatin the figure, the imaging probe is underneath and partially obscured bythe treatment probe. As shown in the figure, the possible range ofmotion for the treatment probe 2304 is of a different shape anddimensions than that of the imaging probe 2306, as viewed from thisperspective.

As is apparent from the figures, in some embodiments each of the probeshas a respective possible range of motion. This possible range of motionrepresents the maximum envelope or boundary region within which thedistal end of the probe can move based on the probe's construction andoperation.

As mentioned, this possible range of motion may be constrained orlimited to prevent collision between the probes and/or the robotic armsthat are used to move the probes. The constraint or limitation may bethe result of a training or teaching process as described herein, wherea physician may manipulate the probes and their respective distal endsto define an allowable range of motion. The training or teaching processmay be performed with the probes outside of a patient and/or inside apatient. Further, images of the treatment probe and/or the interior ofthe patient's body may be used to further constrain or restrict theallowable motion of the probes or robotic arms to prevent collisions orharm to a patient.

FIG. 24 illustrates an isometric view of a treatment probe 1600 and animaging probe 2000 and shows the respective ranges of motion 2402(treatment probe) and 2403 (imaging probe) of the distal ends 2406 ofthe probes overlaid with each other from that perspective, in accordancewith some embodiments. In the figure, the probes are separate butcolinear or parallel to each other with the distal end of the imagingprobe aligned with the distal end of the treatment probe as indicated bythe alignment of the distal ends 2406. The figure shows the asymmetricalenvelope of motion possible for the distal end of the imaging probe fromthat perspective.

FIG. 25A illustrates a side view of the treatment probe 1600 and imagingprobe 2000 of FIG. 24 and shows the respective ranges of motion 2402,2403 of the distal ends 2406 of the probes 1600, 2000, respectively,overlaid with each other from that perspective, in accordance with someembodiments. Note that in comparison with FIG. 22 , the longitudinaldistance 2410 between the pivot points (or fulcrums) on the respectiveprobes is reduced as the distal ends are aligned as indicated by thepositions of distal ends 2406. In this embodiment, the longitudinalseparation 2410 between the two pivot points or fulcrums is for example50 mm or less. This change in relative positioning of the distal ends ofthe two probes in comparison to FIG. 22 impacts the way in which therespective ranges of motion for the probes overlap. This situation couldarise in a treatment of a patient for whom the imaging probe could notbe inserted as far as in the example shown in FIG. 22 and/or duringmovement of the imaging probe in relation to the treatment probe duringtreatment.

FIG. 25B illustrates a side view of the treatment probe 1600 and imagingprobe 2000 of FIG. 24 and shows the respective ranges of motion 2402,2403 of the distal ends of the probes 1600, 2000, respectively, overlaidwith each other from that perspective, in accordance with someembodiments. Note that in this figure, the imaging probe 2000 isadvanced horizontally or longitudinally with respect to the treatmentprobe in comparison to FIG. 25A. As a result, the distal ends of theprobe are not aligned, as in FIG. 25A. This type of change in relativepositioning could result from a difference in patient anatomy, patientinternal organs or tissue, or the treatment being performed. In thisembodiment, the longitudinal separation 2410 between the two pivotpoints or fulcrums is for example 50 mm.

As described, depending upon one or more factors related to thetreatment plan, treatment site, patient positioning, or the patientanatomy (including for example, patient size or health), one or both ofthe treatment or imaging probes may not be able to be inserted or movedin the same manner as for another patient or treatment. This will resultin different positioning of the distal ends of the probes relative toeach other, and therefore a different amount of overlap or orientationof the range of motion envelope(s) for the two probes. Hence, carefulmonitoring of the position, location, orientation and movement of eachprobe relative to the patient and to each other is important to avoidharm to the patient or to the probes due to collisions.

FIG. 26 illustrates a top view of the treatment probe 1600 and imagingprobe 2000 of FIG. 25 and shows the respective ranges of motion 2402,2403 overlaid with each other when the probes 1600, 2000, respectively,are separate but colinear or parallel to each other, in accordance withsome embodiments. In the figure, the distal end of the imaging probe isaligned with the distal end of the treatment probe as indicated bypositions of ends 2406. As seen from the figure, from this perspectiveor view the ranges of motion or envelopes of motion appear symmetrical.

As has been described, during a treatment each of the two probes isinserted into a patient. The imaging probe (or TRUS probe in someexamples) is typically inserted into a patient's rectum or sphinctermuscle, and typically up to the pubic bone. A physician or surgeon canmove the imaging probe within the tissue regions but must be careful notto move the probe into or against bone with force, as that may causeharm to the patient. In some embodiments, a boundary or limit on thepossible motion of the distal end of the probe may be obtained fromstudies of cadavers or other forms of research activities. This may beinstead of, or in addition to a teaching or training session performedby a physician either prior to or after insertion of the probe into apatient.

The treatment probe or handpiece is typically inserted through theurethra for prostate treatments, and towards the pelvic notch in frontof the pubis. This may present a starting point for further manipulationor repositioning of the probe.

FIG. 27 is a flowchart or flow diagram illustrating a method, process,operation or function 2770 for setting a range of motion (ROM) for aprobe used as part of a procedure to treat a patient, in accordance withsome embodiments. With a step 2772, the possible range of motion limitsare set for a treatment probe. As described herein, this may compriseproviding the system with a mathematical or other description of therange of motion or envelope of motion of the probe about a pivot point.

With a step 2774, corresponding possible range of motion limits are setfor an imaging probe. As described herein, this may comprise providingthe system with a mathematical or other description of the range ofmotion or envelope of motion of the probe about a pivot point.

With a step 2776, the possible range of motion for either or both thetreatment probe and imaging probe may be adjusted or modified based onpatient specific factors or parameters. As described herein, this mayinvolve consideration of patient anatomy, a patient scan and/or otherrelevant consideration. This is an optional step and may be performed byexecution of a teaching or training session while the probes areexternal to a patient.

With a step 2778, the probe or probes are connected to the robotic armsof the system and activated to allow the robotic control of thelocation, positioning and orientation of the probe or probes.

With a step 2780, a physician may activate a mode to use the robotic armcontrols to further define, constrain, or restrict the range of motionor positioning for one or both probes, and therefore define theallowable range of motion and desired probe positions for treatment.This may involve a teaching or training session or other form of settingthe desired positions and range of motion for the probes.

With a step 2782, the system may set or fix one or more of the allowablerange of motion for one or both probes, the positioning and alignment ofeach probe with respect to each other both longitudinally and laterally,and/or the positioning and alignment of each probe with respect to thetreatment region.

Although the above steps show a method 2770 for setting a range ofmotion (ROM) for a probe used as part of a procedure to treat a patientin accordance with some embodiments, a person of ordinary skill in theart will recognize many variations based on the teachings describedherein. For example, the steps may be completed in a different order.One or more steps may be added or omitted. Some of the steps maycomprise sub-steps. Many of the steps may be repeated as often asnecessary or desired.

In some sense, there are three possible areas or volumes of interestthat may be used to define or set the allowable or desired range ofmotion, or place constraints on the initial possible range of motion(ROM) of one or both probes. A first volume is that of the possibleand/or allowable range of motion of the two probes relative to eachother. A second volume is that of the possible and/or allowable ROM ofthe imaging probe (inside the patient's rectum). A third volume is thatof the possible and/or allowable ROM of the treatment probe (inside thepatient's prostate/bladder). The first volume or region is to preventcollision of the devices with each other and a distance to maintainbetween the probes to protect against probe collision related tissuedamage. The second volume or region is to establish a safe and desiredtissue manipulation capability within the rectum, independent of theother probe's location. The third volume or region is to establish asafe and desired tissue manipulation capability within the bonestructure, urethra, prostate, and bladder, independent of the otherprobe's location. Note that each region or volume may be establishedseparately and together they function as a rule set that is taken intoaccount when determining if an intersection of the regions or volumesmay occur.

Note that although reference is made to defining, controlling and/orconstraining the range of motion of the distal end or one or both of atreatment or an imaging probe, embodiments are also directed todefining, controlling and/or constraining the range of motion of anentire probe. This may include constraining or limiting the trajectory,motion, vector, alignment, orientation, or other form of positioningand/or motion of a probe. Such a constraint or limitation may be basedon, or take into consideration, one or more of a probe's dimensions, apivot point relative to a patient's anatomy, a relative alignmentbetween a treatment probe and an imaging probe, or other relevantinformation or images.

In some embodiments and uses of the described system, a person willinitially place or position a probe, the probe will be coupled to arobotic arm, and the robotic arm will then be used to move the probe. Arange of motion, boundary of motion, or envelope of motion may bedefined by data input to a computing system that is coupled to therobotic arm(s). The data may comprise measurements, parameter limits,threshold values, specific instructions, images, or other form ofrepresenting a constraint or limit on the possible movement of a probe.

The data may be generated during a training or teaching sessionconducted by a physician, such as by having the physician manipulate theprobe to move it over the allowable range of motion. The allowable rangeof motion as defined by the physician may be modified by information ordata regarding the patient that is stored in a database coupled to thecomputing device. The database may contain a scan, such as a CT or MRI,that provides more detailed information regarding a specific patient'sanatomy and the treatment site. For purposes of ensuring safety to thepatient, a tolerance amount may be used to adjust or modify thedetermined allowable range of motion.

As mentioned, a patient's anatomy may impact how a probe is positionedin the patient. For example, if a patient is obese or has more than anaverage amount of abdominal fatty tissue, then the length of the probeinserted into the patient and initial position of the probe inside thepatient may be different than for a slenderer patient. Also, therelative location of the rectal pivot of the imaging probe and pivot ofthe treatment probe near the pelvic notch may vary, for exampledepending on weight.

In making fine adjustments to the location, position, or orientation ofthe treatment probe, the imaging probe may be used to obtain images ofthe distal end of the treatment probe. The imaging probe is typicallyseveral millimeters in width and for optimal ultrasound imaging, it ishelpful to have contact between the probe and tissue. If sufficientcontact is lacking, then an operator may need to slightly lift the probeslightly, for example. A patient's anatomy may be non-symmetrical andrequire movement of an imaging probe and/or treatment probe to one sideor the other.

As mentioned, avoiding collisions between the probes, collisions betweenthe robotic arms, or collisions between a probe and the tissue or organof a patient are all important in preventing harm and successfullycompleting a treatment. As described herein, avoiding collisions byconstraining or limiting the range of motion of a probe can beaccomplished by several approaches.

A first is a purely manual approach, as is done conventionally. In thisapproach, a physician is responsible for carefully manipulating theprobe or probes to avoid contact with each other or with the tissue ororgans of the patient. The physician may rely on images from the imagingprobe to determine the location of each probe inside the patient and torecognize tissue or other structures inside the patient.

A second approach is to set limits on the possible range of motion ordefine a boundary of a region or envelope in which the probe distal endmay safely move. As described, in one example, a physician maydemonstrate to a computing system a range of allowable motion of aprobe. The computing system may determine from the demonstrated range ofmotion the parameters of allowed motion and these parameters may betranslated into restrictions or limits on the commands or instructionsthat may be applied to the robotic arms and probes. Sensors on the armsor probes may assist in determining the location, position, ororientation of a robotic arm or probe.

A third approach combines the second approach with images from insidethe patient.

This approach may use image recognition or a previously obtained scan ofthe patient to identify tissue or organs inside the patient and combinedwith images of the treatment probe, may be used to provide informationfor controlling movement of the treatment probe. The imaging probe datacan be used to determine how far apart the two probes are, for example.In one example, it may be desirable to maintain a minimum distancebetween the distal ends of the two probes, for example 2 mm.

In some embodiments, a mathematical model or representation of thepossible ranges of motion of each probe may be generated and stored in acomputing device. The possible range of motion or envelope of possiblemotion is typically represented by some form of symmetric or asymmetricconic section. Given the probe dimensions and the points on the probecorresponding to where the probe wands are inserted into the patient(e.g., the pivot points), a computing device can calculate and displaythe relative position, orientation and range of motion of the two probesinside the patient. This display can be modified by information from apatient scan and/or physician to generate a patient-specific display ofthe probes and their respective ranges of motion while inside thepatient. This information may be used to prevent collisions or harm tothe patient by generating an alert, preventing further movement, orother suitable mechanism when (or if) the ends of the probes become tooclose to each other or to the patient's tissue or organs.

As described herein, the computing devices and systems described and/orillustrated herein broadly represent any type or form of computingdevice, processor or system capable of executing computer-readableinstructions, such as those contained within the modules describedherein. In their most basic configuration, these computing device(s) mayeach comprise at least one memory device and at least one physicalprocessor.

The term “memory” or “memory device,” as used herein, generallyrepresents any type or form of volatile or non-volatile storage deviceor medium capable of storing data and/or computer-readable instructions.In one example, a memory device may store, load, and/or maintain one ormore of the modules described herein. Examples of memory devicescomprise, without limitation, Random Access Memory (RAM), Read OnlyMemory (ROM), flash memory, Hard Disk Drives (HDDs), Solid-State Drives(SSDs), optical disk drives, caches, variations or combinations of oneor more of the same, or any other suitable storage memory.

In addition, the term “processor” or “physical processor,” as usedherein, generally refers to any type or form of hardware-implementedprocessing unit capable of interpreting and/or executingcomputer-readable instructions. In one example, a physical processor mayaccess and/or modify one or more modules stored in the above-describedmemory device. Examples of physical processors comprise, withoutlimitation, microprocessors, microcontrollers, Central Processing Units(CPUs), Graphic Processing Units (GPUs), Tensor Processing Units (TPUs),Field-Programmable Gate Arrays (FPGAs) that implement softcoreprocessors, Application-Specific Integrated Circuits (ASICs), portionsof one or more of the same, variations or combinations of one or more ofthe same, or any other suitable physical processor.

Although illustrated as separate elements, the method steps describedand/or illustrated herein may represent portions of a singleapplication. In addition, in some embodiments one or more of these stepsmay represent or correspond to one or more software applications orprograms that, when executed by a computing device, may cause thecomputing device to perform one or more tasks, such as the method step.

In addition, one or more of the devices described herein may transformdata, physical devices, and/or representations of physical devices fromone form to another. Additionally or alternatively, one or more of themodules recited herein may transform a processor, volatile memory,non-volatile memory, and/or any other portion of a physical computingdevice from one form of computing device to another form of computingdevice by executing on the computing device, storing data on thecomputing device, and/or otherwise interacting with the computingdevice.

The term “computer-readable medium,” as used herein, generally refers toany form of device, carrier, or medium capable of storing or carryingcomputer-readable instructions. Examples of computer-readable mediacomprise, without limitation, transmission-type media, such as carrierwaves, and non-transitory-type media, such as magnetic-storage media(e.g., hard disk drives, tape drives, and floppy disks), optical-storagemedia (e.g., Compact Disks (CDs), Digital Video Disks (DVDs), andBLU-RAY disks), electronic-storage media (e.g., solid-state drives andflash media), and other distribution systems.

A person of ordinary skill in the art will recognize that any process ormethod disclosed herein can be modified in many ways. The processparameters and sequence of the steps described and/or illustrated hereinare given by way of example only and can be varied as desired. Forexample, while the steps illustrated and/or described herein may beshown or discussed in a particular order, these steps do not necessarilyneed to be performed in the order illustrated or discussed.

The various exemplary methods described and/or illustrated herein mayalso omit one or more of the steps described or illustrated herein orcomprise additional steps in addition to those disclosed. Further, astep of any method as disclosed herein can be combined with any one ormore steps of any other method as disclosed herein.

The processor as described herein can be configured to perform one ormore steps of any method disclosed herein. Alternatively, or incombination, the processor can be configured to combine one or moresteps of one or more methods as disclosed herein.

Unless otherwise noted, the terms “connected to” and “coupled to” (andtheir derivatives), as used in the specification and claims, are to beconstrued as permitting both direct and indirect (i.e., via otherelements or components) connection. In addition, the terms “a” or “an,”as used in the specification and claims, are to be construed as meaning“at least one of” Finally, for ease of use, the terms “including” and“having” (and their derivatives), as used in the specification andclaims, are interchangeable with and shall have the same meaning as theword “comprising.

The processor, processors, or computing device or devices as disclosedherein can be configured with executable instructions to perform any oneor more steps of any method as disclosed herein. This may beaccomplished by programming a processor with a set ofcomputer-executable instructions. When executed, the instructions willcause the processor or a computing device of which a processor is anelement to implement one or more steps or stages of the methodsdescribed herein.

It will be understood that although the terms “first,” “second,”“third”, etc. may be used herein to describe various layers, elements,components, regions or sections without referring to any particularorder or sequence of events. These terms are merely used to distinguishone layer, element, component, region or section from another layer,element, component, region or section. A first layer, element,component, region or section as described herein could be referred to asa second layer, element, component, region or section without departingfrom the teachings of the present disclosure.

As used herein, the term “or” is used inclusively to refer items in thealternative and in combination.

As used herein, characters such as numerals refer to like elements.

As used herein, the terms “coarse” and “gross” are used interchangeably.

As used herein, the terms “one or more computing devices” and“processor” are used interchangeably.

The present disclosure includes the following numbered clauses.

Clause 1. A system for treating or imaging tissue of a patient, saidsystem comprising: a probe sized for insertion into the patient; arobotic arm configured to couple to the probe; one or more computingdevices operatively coupled to the robotic arm and configured withinstructions for: establishing an allowable range of motion for theprobe, the allowable range of motion stored on a memory of the one ormore computing devices, wherein establishing the allowable range ofmotion further comprises defining a possible range of motion for adistal end of the probe; and modifying the possible range of motion ofthe distal end of the probe to define an allowable range of motion forthe distal end of the probe; treating or imaging the target tissue ofthe patient with the probe; and moving the robotic arm to affectmovement of the probe within the allowable range of motion for theprobe.

Clause 2. The system of clause 1, wherein defining a possible range ofmotion for a distal end of the probe further comprises defining a regionwithin which the distal end of the probe is capable of moving.

Clause 3. The system of clause 2, wherein the region is defined by amathematical representation of the region.

Clause 4. The system of clause 2, wherein the region is defined by animage of the region, the image including dimensions of the probe and thepossible angular movement of the distal end of the probe.

Clause 5. The system of clause 1, wherein the probe is an imaging probeand the system further comprises a treatment probe sized for insertioninto the patient.

Clause 6. The system of clause 5, wherein modifying the possible rangeof motion of the distal end of the probe to define an allowable range ofmotion further comprises activating and performing a training orteaching mode for the system, the training or teaching mode comprising auser manipulating one or both of the imaging or treatment probes todefine a limit on the possible range of motion of the distal end of oneor both of the imaging or treatment probes.

Clause 7. The system of clause 6, wherein the training or teaching modeis conducted when both probes are outside of the patient.

Clause 8. The system of clause 6, wherein the training or teaching modeis conducted when both probes are inside of the patient.

Clause 9. The system of clause 8, further comprising operating theimaging probe to obtain an image of the treatment probe, and in responseto the image, constraining the allowable range of motion of the distalend of the treatment probe.

Clause 10. The system of clause 8, further comprising operating theimaging probe to obtain an image of the treatment probe, and in responseto the image, constraining the allowable range of motion of the distalend of the imaging probe.

Clause 11. The system of clause 10, further comprising operating theimaging probe to obtain an image of the treatment probe, and in responseto the image, automatically moving the distal end of the imaging probewithin a predetermined area to avoid collision with the treatment probe.

Clause 12. The system of clause 8, further comprising operating theimaging probe to obtain an image of the patient's anatomy, and inresponse to the image, constraining the allowable range of motion of thedistal end of the imaging probe.

Clause 13. The system of clause 1, wherein modifying the possible rangeof motion of the distal end of the probe comprises comparing thepossible range of motion to a scan of the patient showing an area of thepatient's anatomy near a treatment site and modifying the possible rangeof motion to avoid harm to the patient from the distal end of the probein a region around the treatment site.

Clause 14. The system of clause 12, further comprising processing theobtained image using an image recognition application to identify anorgan or region of tissue of the patient.

Clause 15. A method of treating target tissue at a target site of apatient, said method comprising: manually inserting a probe into thepatient; coupling the probe to a robotic arm; establishing an allowablerange of motion for the probe, the allowable range of motion stored on amemory of one or more computing devices operably coupled with therobotic arm, wherein establishing the allowable range of motion furthercomprises defining a possible range of motion for a distal end of theprobe; and modifying the possible range of motion of the distal end ofthe probe to define an allowable range of motion for the distal end ofthe probe; treating or imaging the target tissue of the patient with theprobe; and moving the robotic arm under control of the one or morecomputing devices operably coupled with the probe, to affect movement ofthe probe within the allowable range of motion for the probe.

Clause 16. The method of clause 15, wherein defining a possible range ofmotion for a distal end of the probe further comprises defining a regionwithin which the distal end of the probe is capable of moving.

Clause 17. The method of clause 16, wherein the region is defined by amathematical representation of the region.

Clause 18. The method of clause 16, wherein the region is defined by animage of the region, the image including dimensions of the probe and thepossible angular movement of the distal end of the probe.

Clause 19. The method of clause of claim 15, wherein the probe is animaging probe and the system further comprises a treatment probe sizedfor insertion into the patient.

Clause 20. The method of clause 19, wherein modifying the possible rangeof motion of the distal end of the probe to define an allowable range ofmotion further comprises activating and performing a training orteaching mode for the system, the training or teaching mode comprising auser manipulating one or both of the imaging or treatment probes todefine a limit on the possible range of motion of the distal end of oneor both of the imaging or treatment probes.

Clause 21. The method of clause 20, wherein the training or teachingmode is conducted when both probes are outside of the patient.

Clause 22. The method of clause 21, wherein the training or teachingmode defines a range of motion of the first probe relative to the secondprobe, with the defined range of motion able to be stored in memory andtranslatable to inside of the patient.

Clause 23. The method of clause 21, wherein the training or teachingmode is conducted when both probes are inside of the patient.

Clause 24. The method of clause 23, further comprising operating theimaging probe to obtain an image of the treatment probe, and in responseto the image, constraining the allowable range of motion of the distalend of the treatment probe.

Clause 25. The method of clause 23, further comprising operating theimaging probe to obtain an image of the treatment probe, and in responseto the image, constraining the allowable range of motion of the distalend of the imaging probe.

Clause 26. The method of clause 23, further comprising operating theimaging probe to obtain an image of the treatment probe, and in responseto the image, performing one or more of: defining a region or volume toprevent a collision of the probes with each other or a distance tomaintain between the probes to protect against probe collision relatedtissue damage; confirming the position of one or both probes within thedefined region; or monitoring the position of one or both probes andactivating a motion of a robotic arm to prevent a collision.

Clause 27. The method of clause 23, further comprising operating theimaging probe to obtain an image of the patient's anatomy, and inresponse to the image, constraining the allowable range of motion of thedistal end of the imaging probe.

Clause 28. The method of clause 15, wherein modifying the possible rangeof motion of the distal end of the probe comprises comparing thepossible range of motion to a scan of the patient showing an area of thepatient's anatomy near a treatment site and modifying the possible rangeof motion to avoid harm to the patient from the distal end of the probein a region around the treatment site.

Clause 29. The method of clause 27, further comprising processing theobtained image using an image recognition application to identify anorgan or region of tissue of the patient

Clause 30. A system for treating target tissue at a target site of apatient, the system comprising: a first robotic arm coupled to atreatment probe for treating the target tissue of the patient; a secondrobotic arm coupled to an imaging probe for imaging the target tissue ofthe patient; and one or more computing devices operably coupled with thefirst robotic arm and the second robotic arm, the one or more computingdevices configured to execute instructions for controlling movement ofone or more of the first robotic arm or the second robotic arm, whereinthe instructions constrain the movement of one or both probes to bewithin an allowable range of motion for the probe or probes.

Clause 31. The system of clause 30, wherein the one or more computingdevices are configured to execute instructions for controlling themovement of the first robotic arm or the second robotic arm to adjustone or more of a pitch, yaw, roll, lateral, or linear position of thetreatment probe or the imaging probe along an axis of entry of thetreatment probe or the imaging probe into the patient.

Clause 32. The system of clause 30, wherein the instructions forconstraining the movement of one or both probes to be within anallowable range of motion for the probe or probes further includeinstructions for defining a possible range of motion for a distal end ofat least one of the probes and modifying the possible range of motion ofthe distal end of the probe to define an allowable range of motion forthe distal end of the probe.

Clause 33. The system of clause 32, wherein defining a possible range ofmotion for a distal end of the probe further comprises defining a regionwithin which the distal end of the probe is capable of moving.

Clause 34. The system of clause 33, wherein the region is defined by amathematical representation of the region.

Clause 35. The system of clause 33, wherein the region is defined by animage of the region, the image including dimensions of the probe and thepossible angular movement of the distal end of the probe.

Clause 36. The system of clause 32, wherein modifying the possible rangeof motion of the distal end of the probe to define an allowable range ofmotion further comprises activating and performing a training orteaching mode for the system, the training or teaching mode comprising auser manipulating one or both of the imaging or treatment probes todefine a limit on the possible range of motion of the distal end of oneor both of the imaging or treatment probes.

Clause 37. The system of clause 36, wherein the training or teachingmode is conducted when both probes are outside of the patient.

Clause 38. The system of clause 36, wherein the training or teachingmode is conducted when both probes are inside of the patient.

Clause 39. The system of clause 38, further comprising operating theimaging probe to obtain an image of the treatment probe, and in responseto the image, constraining the allowable range of motion of the distalend of the treatment probe.

Clause 40. The system of clause 38, further comprising operating theimaging probe to obtain an image of the treatment probe, and in responseto the image, constraining the allowable range of motion of the distalend of the imaging probe.

Clause 41. The system of clause 38, further comprising operating theimaging probe to obtain an image of the patient's anatomy, and inresponse to the image, constraining the allowable range of motion of thedistal end of the imaging probe.

Clause 42. The system of clause 30, wherein modifying the possible rangeof motion of the distal end of the probe comprises comparing thepossible range of motion to a scan of the patient showing an area of thepatient's anatomy near a treatment site and modifying the possible rangeof motion to avoid harm to the patient from the distal end of the probein a region around the treatment site.

Clause 43. The system of clause 41, further comprising processing theobtained image using an image recognition application to identify anorgan or region of tissue of the patient.

While preferred embodiments of the present invention have been shown anddescribed herein, it will be obvious to those skilled in the art thatsuch embodiments are provided by way of example only. Numerousvariations, changes, and substitutions will now occur to those skilledin the art without departing from the invention. It should be understoodthat various alternatives to the embodiments of the invention describedherein may be employed in practicing the invention. It is intended thatthe following claims define the scope of the invention and that methodsand structures within the scope of these claims and their equivalents becovered thereby.

What is claimed is:
 1. A system for treating or imaging tissue of apatient, said system comprising: a probe comprising a shaft having adistal end configured to be inserted into the patient and a proximal endconfigured to couple to a robotic arm; one or more computing devicesoperatively couplable to the robotic arm and configured withinstructions for: establishing an allowable range of motion for theprobe, the allowable range of motion including a region within which theprobe may move and being stored on a memory of the one or more computingdevices, wherein establishing the allowable range of motion furthercomprises, defining a possible range of motion of the probe, andmodifying the possible range of motion of the probe by moving the probewithin the patient to define the allowable range of motion of the probe;and moving the robotic arm to affect movement of the probe within theallowable range of motion of the probe to treat or image the tissue ofthe patient.
 2. The system of claim 1, wherein defining a possible rangeof motion for a distal end of the probe further comprises defining theregion.
 3. The system of claim 2, wherein the region is defined by amathematical representation of the region.
 4. The system of claim 2,wherein the region is defined by an image of the region, the imageincluding dimensions of the probe and the possible angular movement ofthe distal end of the probe.
 5. The system of claim of claim 1, whereinthe probe comprises an imaging probe and the system further comprises atreatment probe sized for insertion into the patient.
 6. The system ofclaim 5, wherein modifying the possible range of motion of the distalend of the probe to define an allowable range of motion furthercomprises activating and performing a training or teaching mode for thesystem, the training or teaching mode comprising a user manipulating oneor both of the imaging or treatment probes to define a limit on thepossible range of motion of the distal end of one or both of the imagingor treatment probes.
 7. The system of claim 6, wherein the training orteaching mode is conducted when both probes are outside of the patient.8. The system of claim 6, wherein the training or teaching mode isconducted when both probes are inside of the patient.
 9. The system ofclaim 8, further comprising operating the imaging probe to obtain animage of the treatment probe, and in response to the image, constrainingthe allowable range of motion of the distal end of the treatment probe.10. The system of claim 8, further comprising operating the imagingprobe to obtain an image of the treatment probe, and in response to theimage, constraining the allowable range of motion of the distal end ofthe imaging probe.
 11. The system of claim 10, further comprisingoperating the imaging probe to obtain an image of the treatment probe,and in response to the image, automatically moving the distal end of theimaging probe within a predetermined area to avoid collision with thetreatment probe.
 12. The system of claim 8, further comprising operatingthe imaging probe to obtain an image of the patient's anatomy, and inresponse to the image, constraining the allowable range of motion of thedistal end of the imaging probe.
 13. The system of claim 1, whereinmodifying the possible range of motion of the distal end of the probecomprises comparing the possible range of motion to a scan of thepatient showing an area of the patient's anatomy near a treatment siteand modifying the possible range of motion to avoid harm to the patientfrom the distal end of the probe in a region around the treatment site.14. The system of claim 12, further comprising processing the obtainedimage using an image recognition application to identify an organ orregion of tissue of the patient.
 15. A system for treating or imagingtissue of a patient, the system comprising: one or more computingdevices operatively couplable to a robotic arm, the one or morecomputing devices comprising a non-transitory computer readable mediumcomprising instructions that when executed case the system to carry outa method comprising: establishing an allowable range of motion for aprobe, the allowable range of motion including a region within which theprobe may move and being stored on a memory of one or more computingdevices operably coupled with the robotic arm, wherein establishing theallowable range of motion further comprises, defining a possible rangeof motion of the probe, and modifying the possible range of motion ofthe probe by moving the probe within the patient to define the allowablerange of motion of the probe; and moving the robotic arm under controlof the one or more computing devices operably coupled with the probe, toaffect movement of the probe to treat or image the tissue of thepatient.
 16. The system of claim 15, wherein defining the possible rangeof motion for a distal end of the probe further comprises defining theregion.
 17. The system of claim 16, wherein the region is defined by amathematical representation of the region.
 18. The system of claim 16,wherein the region is defined by an image of the region, the imageincluding dimensions of the probe and the possible angular movement ofthe distal end of the probe.
 19. The system of claim of claim 15,wherein the probe comprises an imaging probe and the system furthercomprises a treatment probe sized for insertion into the patient. 20.The system of claim 19, wherein modifying the possible range of motionof the distal end of the probe to define an allowable range of motionfurther comprises activating and performing a training or teaching modefor the system, the training or teaching mode comprising a usermanipulating one or both of the imaging or treatment probes to define alimit on the possible range of motion of the distal end of one or bothof the imaging or treatment probes.